BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1053110 · Received May 28, 2008

    Report

    Report Number
    2024168-2008-00432
    Event Type
    Death
    Date Received
    May 28, 2008
    Date of Event
    April 25, 2008
    Report Date
    April 28, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS SUMMATIONS - FACTORS THAT CAN AFFECT PERFORATION INCLUDE, BUT ARE NOT LIMITED TO, BENT/BROKEN STENT STRUTS, EXPANDING THE STENT ABOVE RBP, POST-DILATING ONLY THE PROXIMAL HALF OF THE STENT/VESSEL AND LESION MORPHOLOGY. THE AGE OF THE GRAFT MAY HAVE BEEN A CONTRIBUTING FACTOR. PERFORATION AND DEATH, AS LISTED IN THE IFU, ARE KNOWN ADVERSE EFFECTS ASSOCIATED WITH CORONARY STENTING, BUT NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. A CONCLUSIVE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: DEATH. REPORTING RATIONALE: DEATH. DEVICE ISSUE: LEAK STENT GRAFT. IT WAS REPORTED THAT AFTER DEPLOYMENT OF THE RX VISION STENT TO TREAT A 19 YEAR OLD GRAFT, A PERFORATION OCCURRED WICH REQUIRED TREATMENT WITH A GRAFTMASTER STENT. IT IS UNSURE IF THE PERFORATION WAS COMPLETELY SEALED; HOWEVER, NO PERFUSION WAS NOTED AND THE PT STARTED TO DECLINE AND GO INTO SHOCK. CPR WAS PERFORMED AND A BALLOON PUMP WAS PLACED; HOWEVER, THE PT PASSED AWAY. 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-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| L| R