BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1652824 · Received April 6, 2010

    Report

    Report Number
    2024168-2010-00700
    Event Type
    Death
    Date Received
    April 6, 2010
    Date of Event
    March 8, 2010
    Report Date
    March 12, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE STENT REMAINED IN THE PT. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE LOT HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFO. THE RX XIENCE V 3.0 X 18 MM (PART#1009541-18/LOT#9122241/(B) (4)) MENTIONED IS BEING FILED UNDER A SEPARATE MFR NUMBER.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. TIME OF ADVERSE EVENT: ONE DAY POST PROCEDURE. ADVERSE EVENT: DEATH. IT WAS REPORTED THAT THE PT HAD CARDIAC CATHETERIZATION OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD) ON (B) (6) 2010. DURING THE PROCEDURE A 3.0 X 18 MM XIENCE V STENT WAS DEPLOYED IN THE PROXIMAL LAD. DURING POST DILATATION OF THE XIENCE V STENT, A VESSEL PERFORATION OCCURRED. A GRAFTMASTER STENT WAS USED TO TREAT THE PERFORATION WITH NO REPORTED ISSUES. PERICARDIOCENTESIS WAS DONE IN THE CATH LAB. HOWEVER, THE PT WENT INTO CARDIAC ARREST. ADVANCED CARDIAC LIFE SUPPORT (ACLS) WAS INITIATED AND THE PT WAS PUT ON INTRA-AORTIC BALLOON PUMP (IABP). THE PT WAS IMMEDIATELY TAKEN TO THE OPERATING ROOM. THE PT UNDERWENT CABG SURGERY TO REPAIR THE LAD ARTERY; WITH A SAPHENOUS VEIN FROM LAD TO AORTA. AFTER BYPASS THE PT REMAINED IN CRITICAL CONDITION, WAS PUT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) MACHINE AND WAS SENT TO ICU WITH THE CHEST OPEN. THE PT CONTINUED TO BLEED FROM THE CHEST AND BLOOD PRODUCTS WERE GIVEN. THE PT ARRESTED AT 12:10 ON (B) (6) 2010 AND EXPIRED AT 12:55 (B) (6) 2010. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER MAF ABBOTT VASCULAR GERMANY NA 577113

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death| L| R RX XIENCE V 3.0 X 18 MM| (PART#1009541-18/LOT#9122241/(B) (4))