BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 4171234 · Received October 14, 2014

    Report

    Report Number
    2024168-2014-06689
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 19, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN A LEFT ANTERIOR DESCENDING ARTERY. A 3.5 X 12 MM OTW GRAFTMASTER WAS ADVANCED TO THE LESION TO TREAT A PERFORATION CAUSED BY A NON-ABBOTT BALLOON CATHETER. THE GRAFTMASTER WAS DEPLOYED, HOWEVER, THERE WAS STILL A SMALL LEAK AT THE DISTAL END OF THE COVERED STENT. A 3.0 X 12 MM GRAFTMASTER WAS THEN DEPLOYED TO SUCCESSFULLY SEAL THE LEAK. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650723 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 741631

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention