BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT

    MDR report key: 1062608 · Received June 18, 2008

    Report

    Report Number
    2242352-2008-00005
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    May 16, 2008
    Report Date
    May 19, 2008
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    MAL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE BATCH NUMBER OF THE DEVICE IS UNK AND APPEARS, AT THIS TIME, TO BE UNATTAINABLE, A REVIEW OF THE DEVICE HISTORY RECORDS IS NOT POSSIBLE. A ROLLING 12-MONTH REVIEW OF THE COMPLAINT HISTORY FOR THE PRODUCT FAMILY SHOWS NO OTHER SIMILAR COMPLAINTS. THE DEVICE HISTORY RECORDS FOR THE MOST PROBABLE BATCHES OF THE SHIP HISTORY WERE REVIEWED. ALL MFG AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH OUR STANDARD PROCEDURES. THE DEVICE HISTORY RECORD FOR THIS BATCH SHOWS THAT THE PRODUCT MET ITS SPECIFICATION AT THE TIME OF RELEASE TO DISTRIBUTION - THERE ARE NO SIMILAR INCIDENTS AGAINST THE BATCHES FROM THE SHIP HISTORY REPORT.

    Description of Event or Problem · 1

    THE IMPLANT COORDINATOR REPORTED, "THE PHYSICIAN WOULD LIKE TO KNOW WHAT THE HEMASHIELD GRAFT IS ACTUALLY MADE OF." THE FOLLOWING ADDITIONAL INFO WAS RECEIVED ON MAY 22, 2008 FROM THE PHYSICIAN: THE ORIGINAL AORTOFEMORAL BYPASS PROCEDURE WAS PERFORMED ON A MALE PT IN 2003. A COPY OF THE OPERATIVE REPORT WAS SENT TO INCLUDE WITH THE COMPLAINT FILE. SIX DAYS PRIOR TO ORIGINAL DATE EVENT DATE COINCIDES WITH A REPAIR TO THE ORIGINAL ILIAC ON THE RIGHT SIDE. (PHYSICIAN STATED A 14 MM X 7 MM HEMASHIELD GRAFT WAS USED FOR THE ILIAC REPAIR, BUT THE EXACT UPN AND BATCH ARE NOT KNOWN). THE EXPLANTED SECTION OF GRAFT IS BEING RETURNED BY THE MATERIALS MANAGER FOR EVALUATION. THE PHYSICIAN WOULD LIKE SEMS PERFORMED TO DETERMINE WHY THE DILATION OCCURRED. ON THE DAY PRIOR TO ORIGINAL DATE, THE PHYSICIAN PERFORMED A REPAIR TO THE RIGHT ILIAC IN SIMILAR FASHION TO THE SIX DAYS PRIOR TO ORIGINAL DATE PROCEDURE. THE MATERIALS MANAGER (ROGER) IS ALSO RETURNING A SECTION OF GRAFT FROM THIS PROCEDURE. THE RGA NUMBERS WERE ALSO ATTACHED TO A DUPLICATE COMPLAINT BEING SUBMITTED FOR CANCELLATION. PT NOTES FOLLOWING THE TWO ILIAC REPLACEMENT PROCEDURES IN 2008: FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT SEALED VASCULAR GRAFT MAL MAQUET CARDIOVASCULAR LLC 085201 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other