Medical Device Daily Washington Editor
The FDA has issued a notification reemphasizing the need for continued surveillance of patients treated with endovascular grafts and providing updated information on the mortality risks associated with the use of the AneuRx Stent Graft System made by Medtronic Vascular (Minneapolis) to prevent abdominal aortic aneurysm (AAA) rupture. This Public Health Notification focuses on the AneuRx Stent Graft System, “the only currently marketed device with a significant number of patients with long-term clinical follow-up at five years,” the agency said.
The notification provides various recommendations, including:
• Clinician consideration of the information available in the product labels and in the yearly clinical updates from Medtronic and other graft manufacturers when selecting treatment options for patients with AAA and in following previously treated patients.
• Use of the AneuRx Stent Graft “only in patients who can be treated in accordance with instructions for use and meeting appropriate risk/benefit profiles. The risks listed include: a greater average rate of AAA-related mortality associated with the AneuRx greater than that associated with open surgery; a mortality rate of open or endovascular AAA repair “considerably higher” when done by inexperienced physicians or at an inexperienced institution; higher average mortality related to increased surgical risk factors. For a 70-year old patient, for example, the rate could range from 2% with no risk factors to over 40% with multiple co-morbidities.
• Patient willingness to comply with the follow-up schedule for the endovascular graft.
FDA said its earlier notifications “suggested an increasing trend in aneurysm-related mortality among AneuRx graft patients,” an estimated late aneurysm-related mortality of about 0.4% a year.
It said it now has additional long-term data indicating that aneurysm-related mortality increases after three years post-implant, reaching 1.3% by year four and 1.5% by year five, rates which it called “substantially higher than the mortality rate for open surgical repair, which averages 0.18% per year with a range of 0% to 0. % per year. These mortality data for open surgical repair are comparable to that presented in the recently published results of the EVAR-1 trial.
FDA said that it had developed the new data by working with Medtronic Vascular after previously determining that the risk of aneurysm-related overall mortality in patients with the AneuRx graft was significantly greater than in those undergoing open surgical repair.
FDA wants more inspection of Baxa
A Jan. 14 warning letter from FDA to Baxa (Englewood, Colorado) cited regarding design controls, but closed by saying that while the agency found the company’s Aug. 29 responses to the inspectional findings adequate, nonetheless “a follow-up inspection will be required.” The letter recommended Baxa provide certification of compliance by an outside expert by May 5 and “bimonthly thereafter until all corrections have been made.”
The lead citation stated that Baxa did not follow its design change procedures when rewriting the operating software for the Exacta Mix 2400 pharmaceutical compounder. According to the warning letter, the Exacta “was the subject of a recall initiated on June 27 ... due to defects that could cause a discrepancy in the total volume added to a solution.”
FDA also said that Baxa had not established acceptance criteria prior to beginning validation studies of a change to two products, the names of which were redacted.
The citation for failure to investigate “all complaints involving the possible failure” of the EM 2400 gave some insight as to the cause of complaints.
The problems include a failure of the software to boot, a bubble detector that was not working properly, and “bubble alarms and intermittent lockup on the touch screen display.” FDA stated that the company could not document the rationale for concluding that normal wear and tear was behind the failures.
FDA also cited Baxa for failure to report two incidents of “serious injury [that] resulted from the incorrect concentrations of solution administered.”
The company’s position was that user error caused the events, but FDA reminded Baxa that regulations “specifically include these types of events as required to be reported.”
Marian Robinson, VP of marketing at Baxa, told Medical Device Daily that FDA has “reviewed our plan and have accepted it,” and that the follow-up inspection will be made in May.
Some warning letters read like primers on 21 CFR Part 820, and the Oct. 18 warning letter to Unipower (Bloomington, Minnesota) was one of those.
The maker of replacement batteries for medical devices, deemed accessory devices by FDA, was cited first for lack of a quality policy. A second citation was for failure to establish complaint handling procedures.
Though the warning letter suggested that Unipower may be unfamiliar with good manufacturing practices, the fifth finding made clear that the company has had previous experience with the agency. That citation said that Unipower was unable to produce any documentation indicating it had calibrated its voltage meters “since the previous FDA inspection in August 2002.”