BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1250037 · Received November 14, 2008

    Report

    Report Number
    2024168-2008-01146
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 15, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - THE DEVICE WAS NOT RETURNED FOR INVESTIGATION; THEREFORE, A CONCLUSIVE ROOT CAUSE FOR THE INABILITY TO CROSS CANNOT BE DETERMINED. IT IS REPORTED THAT THE STENT GRAFT WAS USED PER THE INDICATION TO TREAT A PERFORATION; HOWEVER, THE STENT GRAFT COULD NOT CROSS TO TREAT THE PERFORATION. THERE WAS NO REPORT OF ADD'L TREATMENT OR MEDICAL INTERVENTION TO TREAT THE PERFORATION. IT IS POSSIBLE THAT THE STENT GRAFT DID NOT CROSS BECAUSE OF, BUT NOT LIMITED TO, THE FOLLOWING; TORTUOUS ANATOMY, SEVERELY CALCIFIED VESSELS, PRESENCE OF OTHER DEVICES OR PREVIOUSLY IMPLANTED STENTS.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: GRAFTMASTER DID NOT CROSS TO TREAT THE PERFORATION, AND THIS IS LIKELY TO REQUIRE A SECOND DEVICE AND/OR ADD'L PROCEDURE. DEVICE ISSUE: FAILURE TO CROSS. IT WAS REPORTED THAT THE GRAFTMASTER DID NOT CROSS THE LESION. REPORTEDLY, THERE WERE NO PT EFFECTS. 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 460807

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK