BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1192413 · Received October 7, 2008

    Report

    Report Number
    2024168-2008-00905
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 7, 2008
    Report Date
    September 8, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY. REPORTING RATIONALE: FAILURE TO ADVANCE/DISLODGED STENT REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: FAILURE TO ADVANCE/DISLODGED STENT. IT WAS REPORTED THAT BOTH GRAFTMASTER DEVICES WOULD NOT PASS BEYOND THE VERY PROXIMAL PORTION OF THE SAPHENOUS VEIN GRAFT IN THE RIGHT CORONARY ARTERY AORTIC ANASTOMOSIS, WITH MODERATE STENOSIS. THE GUIDING CATHETER WAS RE-POSITIONED AND A STIFFER GUIDE WIRE WAS USED, BUT THE STENT GRAFT WOULD NOT PASS. WHEN THE 3.5 X 16 MM GRAFTMASTER WAS THEN SELECTED, BUT WITH THE SAME INABILITY TO PASS. WHEN THE 3.5 X 26 MM STENT GRAFT WAS REMOVED FROM THE GUIDING CATHETER, THE STENT HAD DISLODGED FROM THE BALLOON INTO THE GUIDING CATHETER. WHEN THE 3.5 X 16 MM STENT GRAFT WAS WITHDRAWN, A BALLOON WAS QUICKLY INSERTED TO TAMP OFF THE PERFORATION. WHILE THE BALLOON ON THE 3.5 X 16 MM GRAFTMASTER WAS INFLATED, IT WAS NOTED THAT THE STENT GRAFT WAS "MISSING" AND COULD NOT BE SEEN UNDER FLUORO. AFTER TAMPING OFF THE PERFORATION AND BEING SATISFIED WITH THE RESULTS, THE BALLOON/WIRE AND GUIDE CATHETER WERE PULLED OUT AT THE SAME TIME. THE STENT GRAFT WAS FOUND ON THE SHAFT ON THE BALLOON CATHETER AND THE GUIDE WIRE ABOUT 1/2 WAY INSIDE THE GUIDE CATHETER. NO MEDICAL INTERVENTION WAS NEEDED FOR THE RETRIEVAL OF EITHER STENT. 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 520420

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention