BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1656777 · Received April 8, 2010

    Report

    Report Number
    2024168-2010-00725
    Event Type
    Death
    Date Received
    April 8, 2010
    Date of Event
    March 13, 2010
    Report Date
    March 15, 2010
    Manufacturer
    ABBOTT VASCULAR GERMANY
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE LOT HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFORMATION.

    Description of Event or Problem · 1

    DEVICE ISSUE: LEAK - STENT GRAFT. TIME OF ADVERSE EVENT: AFTER PROCEDURE. ADVERSE EVENT: ACTIVE BLEEDING REQUIRING CABG SURGERY/DEATH. IT WAS REPORTED THAT A MINI VISION 2.5 X 08 MM STENT DID NOT CROSS THE LESION. AFTER THE MINI VISIONS FAILED CROSS ATTEMPT; FIVE NON-ABBOTT STENTS WERE DEPLOYED. A PERFORATION OCCURRED DURING POST DILATATION OF A NON-ABBOTT STENT WITH A NON-ABBOTT BALLOON CATHETER. THE TWO GRAFTMASTER STENTS WERE USED AND DEPLOYED WITHOUT A PROBLEM; HOWEVER, THEY DID NOT COMPLETELY SEAL THE LARGER PERFORATION. THE GRAFTMASTER STENTS DID DECREASE THE BLEEDING. THE PATIENT WAS PLACED ON AN INTRA AORTIC BALLOON PUMP (IABP) AND TAKEN TO URGENT CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY. THE PATIENT DIED APPROXIMATELY 36 HOURS ((B) (6) 2010) LATER OF ABDOMINAL BLEEDING WHICH WAS A COMPLICATION OF THE CABG SURGERY. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER MAF ABBOTT VASCULAR GERMANY NA 613462

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death| R STENT: MINI VISION| DILATATION CATHETER: QUANTUM MAVERICK| (X5) MICRO DRIVERS