BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1661890 · Received April 15, 2010

    Report

    Report Number
    2024168-2010-00767
    Event Type
    Death
    Date Received
    April 15, 2010
    Date of Event
    March 11, 2010
    Report Date
    March 22, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE GRAFTMASTER REMAINS IN THE PT. THE DELIVERY DEVICE WAS DISCARDED. A LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFO. THE 3.0X19MM GRAFTMASTER (PART 12744-19, LOT 52653), INDICATED, WILL BE FILED UNDER A SEPARATE MFR#. ADDITIONAL INFO FROM VOLUNTARY REPORT: (B) (6): CATALOG# - 6661935 UA. (B) (6)

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. TIME OF ADVERSE EVENT: AFTER USE. ADVERSE EVENT: PT DEATH. IT WAS REPORTED THAT THE PT PRESENTED TO THE CARDIAC CATH LAB WITH ACUTE ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI). ANGIOGRAPHY REVEALED ACUTE RIGHT CORONARY ARTERY (RCA) OCCLUSION. CORONARY STENT PLACEMENT WITH A NON-ABBOTT STENT RESULTED IN ACUTE PERFORATION OF THE VESSEL, HEMOPERICARDIUM, AND CARDIAC TAMPONADE. TWO GRAFTMASTER STENTS WERE PLACED AND CONTROLLED THE BLEEDING. PERICARDIOCENTESIS WAS PERFORMED. THE PT EXPIRED AFTER THE PROCEDURE OF REFRACTION VENTRICULAR FIBRILLATION WITH A RE-ACCUMULATION OF BLOOD IN THE PERICARDIUM. DATE OF DEATH IS (B) (6) 2010. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE. USER FACILITY MEDWATCH REPORT RECEIVED THAT READS, "(B) (6) WF WITH ACUTE STEMI. ANGIOGRAPHY REVEALED ACUTE RIGHT CORONARY ARTERY OCCLUSION. CORONARY STENT PLACEMENT RESULTED IN ACUTE PERFORATION OF THE VESSEL AND HEMOPERICARDIUM AND CARDIAC TEMPONADE. TWO JOMED COVERED STENTS WERE PLACED WITH CONTROL OF BLEEDING. PERICARDIOCENTESIS WAS PERFORMED. THE PT EXPIRED AFTER PROCEDURE OF REFRACTORY VENTRICULAR FIBRILLATION WITH RE-ACCUMULATION OF BLOOD IN THE PERICARDIUM". ADDITIONAL INFO FROM VOLUNTARY REPORT: THERAPY DATES: (B) (6) 2010. DIAGNOSIS FOR USE: CORONARY PERFORATION. EVENT ABATED AFTER USE STOPPED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER MAF ABBOTT VASCULAR GERMANY NA 524227

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death 3.0 X 19 MM GRAFTMASTER (PART 12744-19, LOT 52653)| JOSTENT 3.5 X 19| STENT: MEDTRONIC 3.5X24MM