BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1672721 · Received April 30, 2010

    Report

    Report Number
    2024168-2010-00893
    Event Type
    Death
    Date Received
    April 30, 2010
    Date of Event
    April 6, 2010
    Report Date
    April 7, 2010
    Manufacturer
    ABBOTT VASCULAR GERMANY
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) (B) (4). EVAL SUMMARY: THE STENT REMAINS IN THE PT. REPORTEDLY, THE PERFORATION WAS CAUSED BY A NON-ABBOTT PRODUCT AND THE GRAFTMASTER WAS PLACED AT THE PERFORATION, BUT COVERAGE WAS NOT OPTIMAL. FAILURE TO SUCCESSFULLY COVER A PERFORATION CAN BE AS A RESULT OF SEVERAL FACTORS WHICH INCLUDE, BUT ARE NOT LIMITED TO THE INTERACTION WITH PT ANATOMY AND/OR THE INTERACTION WITH AN IMPLANTED STENT AND/OR ACCESSORIES USED IN CONJUNCTION WITH THE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER DURING THE PROCEDURE. TECHNIQUE, STENT SIZE SELECTION, VISUALIZATION, CASE SEVERITY, AND PT ANATOMY ALSO INFLUENCE THE PERFORATION SEALING CHARACTERISTICS OF A PTCA DEVICE. A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    DEVICE ISSUE: LEAK FAILURE TO SEAL PERFORATION. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: ACTIVE BLEEDING REQUIRING SURGICAL INTERVENTION/MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK/DEATH. ONSET OF ADVERSE EVENT: DURING THE PROCEDURE. IT WAS REPORTED THAT THE GRAFTMASTER STENT WAS USED TO TREAT A PERFORATION THAT OCCURRED IN THE OBTUSE MARGINAL BRANCH WITH THE USE OF A NON-ABBOTT COMPLIANT BALLOON CATHETER. THE GRAFTMASTER WAS PLACED AT THE PERFORATION, BUT COVERAGE WAS NOT OPTIMAL DUE TO THE EXTENT OF THE PERFORATION. THE PT WAS TAKEN TO SURGERY AND WAS TREATED WITH CORONARY ARTERY BYPASS GRAFT (CABG), WHICH WAS SUCCESSFUL AND CONTROLLED THE BLEEDING. THE PT THEN SUFFERED A MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK AND DIED ON (B) (6) 2010. NO ADD'L INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER MAF ABBOTT VASCULAR GERMANY NA 539428

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| L| R| S NON-ABBOTT BALLOON CATHETER