BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1060247 · Received June 11, 2008

    Report

    Report Number
    2024168-2008-00476
    Event Type
    Injury
    Date Received
    June 11, 2008
    Date of Event
    April 28, 2008
    Report Date
    May 12, 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
    CT, 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 IN ANOTHER COUNTRY, AS PER SPECIFICATIONS. INFO REGARDING ADDITIONAL INTERVENTION TO SEAL THE PERFORATION IS NOT PROVIDED IN THE INCIDENT REPORT. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION; THEREFORE, NO COMPLAINT ROUTE CAUSE CAN BE IDENTIFIED. A SECOND GRAFTMASTER STENT IS BEING REPORTED UNDER ANOTHER MANUFACTURING NUMBER.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/REQUIRED INTERVENTION. REPORTING RATIONALE: PERFORATION NOT SEALED, REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: FAILURE TO ADVANCE. IT WAS REPORTED THAT A PERFORATION OCCURRED WITH THE USE OF ANOTHER DEVICE WHICH REQUIRED TREATMENT WITH A GRAFTMASTER STENT. A 5.0 GRAFTMASTER AND A 4.5 GRAFTMASTER COULD NOT CROSS THE LESION; THEREFORE, ANOTHER DEVICE WAS USED TO SEAL THE PERFORATION. 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 362957

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention STENT: JOSTENT GRAFTMASTER 4.5