BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1060466 · Received June 13, 2008

    Report

    Report Number
    2024168-2008-00492
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 15, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION: PRODUCT PERFORMANCE ENGINEERING DETERMINED THAT THE DEVICE WAS IN WORKING ORDER AND LEFT ABBOTT VASCULAR INSTRUMENTS, AS PER SPECIFICATIONS. IT IS REPORTED THAT THE IMPLANTED STENT GRAFT JAILED A DIAGONAL ARTERY AND CAUSED DIAGONAL ARTERY OCCLUSION; HOWEVER, IT IS STATED IN THE IFU UNDER "STENT GRAFT PLACEMENT - PRECAUTIONS" THAT THE PLACEMENT OF A STENT GRAFT WILL "COMPROMISE SIDE BRANCH PAT-ENTCY". IT IS ALSO STATED IN THE SAME SECTION THAT THE STENT GRAFT SHOULD NOT BE EXPANDED IF IT IS "NOT PROPERLY POSITIONED IN THE VESSEL". NO DEVICE MALFUNCTION CAN BE DETERMINED DUE TO THE LACK OF PROCEDURE AND PT INFO AND THE LACK OF DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY / PERMANENT DAMAGE. REPORTING RATIONALE: OCCLUSION REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NONE. IT WAS REPORTED THAT THE STENT DEPLOYED PROXIMAL TO THE PERFORATION; THEREFORE, A DIAGONAL ARTERY BECAME JAILED AND CAUSED DIAGONAL ARTERY OCCLUSION. THE ARTERY WAS LEFT OCCLUDED. NO TREATMENT WAS ADMINISTERED. NO ADD'L 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 359080

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability