BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALBOGRAFT POLYESTER KNITTED VASCULAR GRAFT

    MDR report key: 2896755 · Received November 21, 2012

    Report

    Report Number
    1220948-2012-00019
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 29, 2012
    Manufacturer
    LEMAITRE VASCULAR
    Product Code
    MAL
    PMA / PMN Number
    K103080
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE RECEIVED THE COMPLAINT GRAFT FOR EVAL AND WERE ABLE TO CONFIRM THE FAILURE. THE ROOT CAUSE OF THE FAILURE IS MISSING THREAD IN THE TEXTILE TUBE DUE TO MFG PROCESS FAILURE. GRAFTS THAT WERE PRODUCED OFF THE SAME TEXTILE MACHINE - SEQUENTIALLY BEFORE AND AFTER - WERE TESTED AND NO ISSUES WERE SEEN. THIS DATA INDICATES THAT THIS IS AN ISOLATED INCIDENT. HOWEVER, WE HAVE INITIATED A CORRECTIVE AND PREVENTIVE ACTION (CAPA (B)(4)) TO PREVENT REOCCURRENCES OF SIMILAR COMPLAINTS IN THE FUTURE. WE HAVE ALSO IMPLEMENTED ADD'L VISUAL INSPECTIONS TO BETTER SCREEN FOR THESE TYPES OF DEFECTS. PLEASE NOTE THAT THE PHYSICIAN DID NOT RELATE THE ALBOGRAFT FAILURE WITH THE PT'S DEATH AND FURTHER CONFIRMED THAT THE IMPLANTED ALBOGRAFT WAS PROPERLY FUNCTIONING UPON INTERVENTION.

    Description of Event or Problem · 1

    WHILE RECONSTRUCTING THE PROXIMAL PART WITH AN OCTOPUS TECHNIQUE (COELIAC, SMA, RENALS) WITH A VASCUTEK BIFURCATED GRAFT + 2 ULTRATHIN 6 MM GRAFTS FOR THE RENALS, THE ALBOGRAFT (18 MM) WAS IMPLANTED IN INFRARENAL POSITION ON A LENGTH OF 10 - 12 CM. DURING THE INITIAL OPERATION AFTER THE ALBOGRAFT WAS IMPLANTED FOR APPROX 15 - 20 MIN A SUDDEN BLEEDING IN THE INFRARENAL OPERATION SITUS WAS NOTED. THE ALBOGRAFT BLACK GUIDELINE (SIDE WITH 1 GUIDELINE) WAS NOTICED AS BLEEDING SOURCE: THE LEAKING WAS THROUGH A LONGITUDINAL SLOT ALONG THE BLACK GUIDELINE. THE SLOT WAS LOCATED APPROX 1 CM FROM THE PROXIMAL INFRARENAL ANASTOMOSIS AND THE LENGTH WAS 1.5 TO 2 CM. THE LEAKING PART OF THE GRAFT WAS EXPLANTED (CUT OFF) AND REPLACED WITH VASCUTEK GRAFT. THE OTHER PART OF THE GRAFT REMAINED IMPLANTED. AFTER COMPLETION OF THE PROCEDURE, THE PT WENT TO ICU AND THE PT WAS UNDER PHYSICIAN CONTROL. LATER, THE PT HAD AN EMBOLI (COLD LEFT LEG) AND WAS SENT TO OPERATING ROOM: INITIAL EMBOLECTOMY AND RESTORATION OF THE ILIAC ARTERY BLOOD FLOW. THE ILIAC ARTERY OCCLUDED AGAIN AND ANOTHER EMBOLECTOMY PROCEDURE WAS DONE. DURING A FURTHER INTRAOPERATIVE ANGIOGRAPHY THE PT SUFFERED FROM A SUDDEN HEART ARREST. THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALBOGRAFT POLYESTER KNITTED VASCULAR GRAFT ALBOGRAFT (STRAIGHT) MAL LEMAITRE VASCULAR AMC1518 46496

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R