BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1231641 · Received November 14, 2008

    Report

    Report Number
    2024168-2008-01145
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 16, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION- ENGINEERING REVIEWED THE INCIDENT INFORMATION. IT IS POSSIBLE THAT THE STENT GRAFT DID NOT COMPLETELY SEAL THE PERFORATION BECAUSE OF, BUT NOT LIMITED TO, THE FOLLOWING: INCORRECT SIZING OF THE STENT GRAFT IN RELATION TO THE SIZE OF THE PERFORATION OR NOT IMPLANTING THE STENT GRAFT CENTRALLY OVER THE PERFORATION. THE STENT GRAFT WAS NOT USED AS PER THE INDICATION TO TREAT A FREE PERFORATION IN NATIVE CORONARY VESSELS OR SAPHENOUS VEIN BYPASS GRAFTS - IT WAS USED OFF-LABEL TO TREAT AN ACTIVE BLEED IN THE SUPERFICIAL FEMORAL ARTERY.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: UNABLE TO COMPLETELY SEAL PERFORATION REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: UNABLE TO COMPLETELY SEAL PERFORATION. IT WAS REPORTED THAT ANOTHER COMPANY'S 0.14 GUIDE WIRE CROSSING THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) CAUSED AN ACTIVE BLEED, SO THE JOSTENT GRAFTMASTER WAS AVAILABLE FOR RAPID DEPLOYMENT; HOWEVER, IT DID NOT COMPLETELY SEAL THE PERFORATION. ANOTHER COMPANY'S .035 GUIDE WIRE AND GRAFT STENT WERE USED TO SEAL THE VESSEL. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 505808

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention GUIDE WIRE: 0.35