BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1414449 · Received July 13, 2009

    Report

    Report Number
    2024168-2009-01237
    Event Type
    Injury
    Date Received
    July 13, 2009
    Date of Event
    June 16, 2009
    Report Date
    June 18, 2009
    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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING DETERMINED THAT IT IS POSSIBLE THAT THE STENT GRAFT DID NOT COMPLETELY SEAL THE PERFORATION BECAUSE OF, BUT NOT LIMITED TO, THE FOLLOWING: THE STENT GRAFT WAS NOT CENTRALLY DEPLOYED OVER THE PERFORATION, THE PERFORATION GREW DURING THE DEPLOYMENT OF THE STENT GRAFT OR THE INCORRECT SIZE OF STENT GRAFT WAS CHOSEN FOR THE PERFORATION, E.G. TOO SHORT. NO DEVICE MALFUNCTION CAN BE DETERMINED DUE TO THE LACK OF PROCEDURE AND PATIENT INFORMATION AND THE LACK OF DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - SURGICAL INTERVENTION. REPORTING RATIONALE: PERFORATION NOT SEALED, RESULTING IN SURGICAL INTERVENTION. DEVICE ISSUE: LEAK - STENT GRAFT. IT WAS REPORTED THAT A GRAFTMASTER STENT WAS IMPLANTED IN THE LAD TO TREAT A PERFORATION CAUSED BY A NON ABBOTT VASCULAR DEVICE; HOWEVER, THE PERFORATION WAS NOT SEALED AND THE PATIENT WENT TO THE OPERATING ROOM FOR A PERICARDIAL WINDOW. THE PERFORATION WAS SUCCESSFULLY TREATED. 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 532779

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention