BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 3930363 · Received July 11, 2014

    Report

    Report Number
    2024168-2014-04479
    Event Type
    Death
    Date Received
    July 11, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE PATIENT EFFECT OF DEATH, AS LISTED IN THE TWO GRAFTMASTER INSTRUCTIONS FOR USE, IS A KNOWN PATIENT EFFECT THAT MAY BE ASSOCIATED WITH THE USE OF JOSTENT CORONARY STENT GRAFT IN NATIVE CORONARY ARTERIES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY INTERVENTION A PERFORATION OCCURRED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. A GRAFTMASTER WAS ADVANCED, BUT WAS UNABLE TO REACH THE PERFORATION DUE TO ANATOMY. CARDIOPULMONARY RESUSCITATION (CPR) WAS STARTED, BUT APPROXIMATELY 20 MINUTES LATER, THE PATIENT EXPIRED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406458 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 713075

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Death