The Food and Drug Administration Issues Warning Letter
Inspections of manufacturing facilities are not unusual. In fact, most drug makers and medical device manufacturers must be subjected to inspections of their plants.
A recent inspection of two facilities involved in the manufacture of the Bard’s inferior vena cava filters (IVC) resulted in a strongly worded letter to a Bard executive that no one in management wants to receive.
In a letter to Timothy Ring, CEO of C.R. Bard, dated July 13, 2015, the Food and Drug Administration’s (FDA) Los Angeles District office warned that the company facility in Queensbury, New York, was inspected in October 2014 through November 2014. Also the Tempe, AZ offices of Bard Peripheral Vascular facility were inspected in November 2014 through January 2015.
Inspections found violations at both facilities that manufacture the inferior vena cava (IVC) filters and components including the Denali Filter the Simon Nitinol Filter and Recovery Cone Removal Kit.
What they found were adulterated and misbranded medical devices at the Tempe, Arizona facility.
The Recovery Cone Removal System, Model RC-15 was marketed without any clearance or approval by the FDA. The Recovery Cone Removal System is a surgical instrument created to remove the Recovery IVC Filter, the G2X filter and the G2Express Filter and the G2 Filter. However the Cone System Model RE-15 was not included in any applications for IVC filters.
This is a violation of how medical devices are supposed to be brought to market.
Initially, a company is supposed to notify the FDA that it intends to market a device. Under the 510(k) approval process, Bard has to claim that its device is the “substantial equivalent” of a device already on the market. Clinical trials are not required, but the notification to market is required by the FDA’s Federal Food, Drug and Cosmetic Act.
The letter says the Recovery Cone Removal system is “adulterated” because Bard did not seek an application for premarket approval. Bard was also told in this letter the Recovery Cone Removal System is “misbranded” because the company did not file the necessary paperwork to sell the device under 510(k).
Bottom line- Bard is illegally marketing the Recovery Cone Removal System in the United States with no marketing clearance or approval which is required by the FDA.
To make matters worse, Bard did not submit any correspondence to answer these violations.
The complaints do not stop there. Bard then made a Recovery Cone Removal System, Model FBRC and again it failed to seek any marketing clearance or approval from the FDA to do so. It too is considered “adulterated” and “misbranded” because it was introduced into interstate commerce for sale without alerting the agency.
For its part, Bard says the Recovery Cone Removal System Model FBRC is a class I or low-risk surgical snare and therefore it is exempt from premarket notification. In this letter, the FDA does not buy that. It says the FBRC is intended for uses that are different from those legally marketed devices under 21 CFR (Code of Federal Regulations) surgical instruments, meaning they are used for general surgical procedures.
The FBRC is intended to be used within the specialty of cardiovascular surgery. It is not exempt from premarket notification.
The FDA is not known to come down very hard on these types of violations. It simply asks a premarket approval application be submitted to the agency. The letter even gives the web page containing the information Bard will need to include. Then after the paperwork is submitted, the FDA will decide whether the product may be legally marketed.
In the letter, the FDA “requests” Bard Peripheral Vascular “immediately cease activities that result in the misbranding or adulteration of the Recovery Cone Removal System, Model RC-15 and the Recovery Cone Removal System, Model FBRC, such as the commercial distribution of the devices for the uses discussed above.”
Sort of like a slap on the wrist.
These were not the only violations that were found.
The inspections noted the Tempe, Arizona plant where the IVC Denali Filter Delivery System (a redesigned vena cava filter) is made is also “misbranded” because Bard failed to furnish information regarding the devices that is required. The Tempe Peripheral Vascular Facility had no system for reviewing and evaluating complaints or initiating an investigation.
For example, if a complaint came in that an IVC filter had detached arm which led to a hemorrhaged right lung and resulted in a death, that was filed as a malfunction, not a death.
Complaints included a detached filter limb that resulted in heart catheterization of the Eclipse filter; a G2 filter that broke and required surgical intervention; a Denali Jugular System that had a detached filter arm that embedded in the IVC wall and required filter retrieval; a G2 Express filter that perforated the IVC and caused an aneurysm. At least ten patients had unsuccessful IVC surgical procedures. But the complaints filed did not document adequately what went wrong.
That means the FDA has no idea what is going on if a medical device is showing indications it is defective.
When a medical device manufacturer such as C.R. Bard receives “adverse event” or complication reports, these are supposed to be taken seriously and noted. The inspection of the Tempe, AZ plant also revealed the company failed to forward a report to the FDA that suggested its device malfunctioned and represented a risk of death or serious injury. A Medical Device Report needed to be submitted for each complaint and was not.
Again in sort of a slap on the wrist, the letter reminds Bard that manufacturers are supposed to submit electronic Medical Device Reports to the FDA under the final rule that took place on August 14, 2015. The letter provides the website for how to submit those reports.
At the Queensbury, New York facility where IVC filter are treated and processed with agents including nitric acid, methanol, sulfamic acid, glycolic acid, citric acid and/or hydrofluoric acid, there was no information to validate that the chemical cleaners were cleared from the medical devices and returned to “acceptable levels.” The FDA letter urges they perform exhaustive extraction testing for Denali Filters to ensure no residuals are present on these devices.
The manufacturing plant failed to process a radial force functional test for the Denali Filter Part and failed in confirming that products it received conformed to specific requirements, in other words, there was little oversight over the quality of product it received that would go into the medical device final product. Filter dimensions of the Denali were not confirmed with the supplier, yet they evaded inspection and ended up in the inventory of finished Denali IVC Filter devices. Bard had 15 days to tell the FDA what it planned to do to take corrective steps in these matters.