BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1920339 · Received December 10, 2010

    Report

    Report Number
    2024168-2010-02674
    Event Type
    Death
    Date Received
    December 10, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 16, 2010
    Manufacturer
    AV-RANGENDINGEN
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. STENTS: RX ZETA PART 1009835-28, LOT UNK; VISION STENT. THE JOSTENT GRAFTMASTER (PART 12746-16, LOT 586059)AND THE RX ZETA (PART 1009835-28, LOT UNK) INDICATED ARE BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. DEATH IS A KNOWN ADVERSE EVENT LISTED IN THE GRAFTMASTER OTW INSTRUCTIONS FOR USE. 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 IN THE SAPHENOUS VEIN GRAFT (SVG) TO THE RIGHT CORONARY ARTERY, A 4.0X38 RX ZETA STENT WAS DEPLOYED FOR TREATMENT OF STENOSIS. STAINING WAS OBSERVED IN THE SVG. A 3.5X28 VISION STENT WAS SUCCESSFULLY DEPLOYED FOR TREATMENT OF THE STENOSIS FOLLOWED BY DEPLOYMENT OF TWO GRAFTMASTER STENTS FOR TREATMENT OF THE PERFORATION. THE PERFORATION WAS REPORTED TO BE MASSIVE AND THE PERICARDIUM RAPIDLY FILLED WITH BLOOD. THE PATIENT WAS INTUBATED PER PROTOCOL AND RESUSCITATION EFFORTS WERE INITIATED INCLUDING A TEMPORARY PACEMAKER, PERICARDIOCENTESIS AND CARDIOPULMONARY RESUSCITATION. PER THE FAMILY'S REQUEST, SURGERY WAS NOT PERFORMED AND THE PATIENT EXPIRED. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-RANGENDINGEN 631239

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death JOSTENT GRAFTMASTER(12746-16/(B)(4))