BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1953230 · Received January 7, 2011

    Report

    Report Number
    2024168-2011-00145
    Event Type
    Death
    Date Received
    January 7, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. DEATH AND ARRHYTHMIA ARE KNOWN ADVERSE EVENTS AS LISTED IN THE GRAFTMASTER OTW INSTRUCTIONS FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP, IF ANY, TO THE DEVICES CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, A JOSTENT GRAFTMASTER OTW STENT GRAFT WAS USED TO SUCCESSFULLY SEAL A PERFORATION IN THE RIGHT CORONARY ARTERY THAT WAS NOT CAUSED BY AN ABBOTT DEVICE. THE EASE OF THE DEVICE WAS REPORTED AS EXCELLENT. THE PATIENT EXPIRED IN THE INTENSIVE CARE UNIT. THE REPORTED CAUSE OF DEATH IS AN ARRHYTHMIA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 629215

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death