BEUDAMED
    FDA Adverse Event Other Summary report: N

    GELWEAVE

    MDR report key: 1512861 · Received April 17, 2009

    Report

    Report Number
    9612515-2009-00005
    Event Type
    Other
    Date Received
    April 17, 2009
    Date of Event
    March 9, 2009
    Report Date
    April 16, 2009
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD - QC AND MFG RECORDS WERE REVIEWED. VASCUTEK CARRIED OUT A LITERATURE REVIEW ABOUT THE ORGANISM MYCOBACTERIUM CHELONAE. RESULTS - THE MFG RECORDS REVEALED THAT THE BATCH 85866/2A WAS STERILIZED FOLLOWING A VALIDATED PROCESS IN STERILIZER NO 4, GIVING A STERILITY ASSURANCE LEVEL OF 1 IN 1 MILLION. THE ALLOCATED STERILE LOT # WAS 0666 ON (B)(6) 2008. THE TOTAL NUMBER OF GRAFTS STERILIZED IN STERILE LOT # 0666 WERE 288. THE USAGE RATES ARE SUCH THAT WE WOULD EXPECT THAT THE MAJORITY OF THESE GRAFTS WOULD HAVE BEEN IMPLANTED. THERE HAVE BEEN NO REPORTS OF INFECTIONS FROM THE OTHER GRAFTS IN THE STERILE LOT NUMBER. A REVIEW OF THE LITERATURE SHOWED THAT MYCOBACTERIUM CHELONAE (REF1) IS A TYPE OF BACTERIA RELATED TO THAT WHICH CAUSES TUBERCULOSIS AND WHICH IS COMMONLY FOUND IN SOIL AND SOMETIMES IN SPUTUM. THEY (REF 2) HAVE ALSO BEEN FOUND IN NATURAL AND PROCESSED WATER SOURCES AS WELL AS IN SEWAGE AND ARE ESPECIALLY COMMON IN TAP WATER. IT (REF 1) IS ONE OF A GROUP OF RAPIDLY GROWING MYCOBACTERIA THAT CAN CAUSE POSTOPERATIVE WOUND INFECTIONS IN SOFT TISSUE AND BONE, IN OTHERWISE HEALTHY PERSONS AND DISSEMINATED DISEASE IN PEOPLE WITH IMPAIRED IMMUNE FUNCTION. CONCLUSION - THE LOT WAS STERILIZED IN STERILE LOT # 0666 IN (B)(6) 2008, CONTAINING 288 FINISHED GRAFT PRODUCTS. THERE HAS BEEN NO RECORD OF INFECTIONS FROM OTHER BATCHES IN THE STERILE LOT. VASCUTEK BELIEVES THAT THE DEVICE WAS SUPPLIED STERILE AS DISPATCHED FROM THE FACILITY. THEREFORE VASCUTEK WOULD CONCLUDE THAT THERE WAS NO DEVICE FAILURE. VASCUTEK WILL WRITE TO THE REPORTER AND REPORT THEIR RESPONSE IN A F/U REPORT. (B)(6) - DEFINITION OF MYCOBACTERIUM CHELONAE. (B)(4) - MYCOBACTERIUM CHELONAE.

    Description of Event or Problem · 1

    VASCUTEK LTD RECEIVED A COPY OF THE ORIGINAL MEDWATCH REPORT SENT TO THE FDA BY THE (B)(6) MED CTR, REFERENCE 390164000-2009-00008, PT IDENTIFIER # (B)(6) ON (B)(6) 2009. THE MEDWATCH REPORT WAS AS FOLLOWS: PT HAD AORTIC ROOT REPLACEMENT WITH PORCINE AORTIC VALVE REPLACEMENT ON (B)(6) 2008. RE-ADMITTED WITH MYCOBACTERIUM CHELONAE INFECTION OF THE GRAFT AND VALVE. BOTH THE GRAFT AND VALVE WERE REPLACED IN THE OPERATING ROOM ON (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELWEAVE VASCULAR PROSTHESIS DSY VASCUTEK LTD. UNK 85866/2A 0666

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization