BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMASHIELD WOVEN DOUBLE VELOUR GRAFT

    MDR report key: 1991234 · Received February 11, 2011

    Report

    Report Number
    2242352-2011-00002
    Event Type
    Death
    Date Received
    February 11, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 14, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY PRODUCT REMAINS IMPLANTED AT THIS TIME. THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED AS REQUIRED. ALL MANUFACTURING AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH APPLICABLE QUALITY PROCEDURES. FOLLOWING OUR INVESTIGATION, SINCE NO PRODUCT IS AVAILABLE FOR EVALUATION, OUR CONCLUSION TO THE MOST PROBABLE ROOT CAUSE CAN NOT BE DETERMINED AT THIS TIME. THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED AS REQUIRED. ALL MANUFACTURING AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH APPLICABLE QUALITY PROCEDURES. THE PRODUCTION BATCH RECORD FOR THIS PRODUCT SHOWS THAT IT WAS RELEASED IN ACCORDANCE WITH ALL GOVERNING QUALITY ASSURANCE/QUALITY CONTROL PROCEDURES PRIOR TO DISTRIBUTION. THERE ARE NO SIMILAR OR OTHER COMPLAINTS AGAINST THE BATCH. (B)(4).

    Description of Event or Problem · 1

    PATIENT'S SPOUSE CALLED TO PROVIDE AN UPDATE THAT HER HUSBAND HAD PASSED ON (B)(6) 2011. HE HAD REPORTEDLY FALLEN ONTO HIS CHEST WHICH RESULTED IN THE RUPTURE OF A SMALL ANEURYSM. HE WAS ADMITTED TO THE (B)(6) EMERGENCY ROOM, WHERE HE LATER EXPIRED. HIS PRIMARY PHYSICIAN, DR (B)(6), WAS UNAVAILABLE AT THE TIME OF THE PATIENT'S ADMITTANCE. THE SPOUSE DID SAY THAT SHE SPOKE WITH HIS IMPLANTING PHYSICIAN AND HE WAS AWARE OF THE ANEURYSM, BUT DUE TO AGE AND HEALTH, IT WAS ONLY BEING MONITORED. DURING THE CALL WITH THE PATIENT'S SPOUSE, WE UPDATED PATIENT INFORMATION IN OUR TRACKING DATABASE AND WERE ABLE TO DETERMINE THE CATALOG AND BATCH, IMPLANT DATE AND IMPLANTING PHYSICIAN INFORMATION. CATALOG: 175628, BATCH: 636163, THE GRAFT WAS IMPLANTED ON (B)(6) 1997, AND THE IMPLANTING PHYSICIAN WAS DR (B)(6). THE (B)(6) MEDICAL CENTER REQUESTED TO PERFORM AN AUTOPSY, AND SHE GRANTED THEM PERMISSION. SHE WAS INFORMED THAT SHE WOULD RECEIVE A COPY OF THE FINISHED REPORT. SHE SAID IF THEY DID PROVIDE THE REPORT TO HER, SHE WOULD CONTACT US TO PROVIDE US WITH A COPY. IF WE DO, WILL PROVIDE THAT INFORMATION IN A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD WOVEN DOUBLE VELOUR GRAFT VASCULAR GRAFTS DSY MAQUET CARDIOVASCULAR, LLC 175628 636163

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Death