BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2834454 · Received November 15, 2012

    Report

    Report Number
    2024168-2012-07228
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    August 7, 2012
    Report Date
    October 22, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    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 FOR THE LOT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT RETURNING. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A LESION IN THE ILIAC ARTERY, A PERFORATION OCCURRED. THE 3.0 X 16 MM GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT COULD NOT CROSS TO THE PERFORATION DUE TO RESISTANCE WITH THE VESSEL. PROLONGED BALLOON INFLATIONS WERE USED TO SEAL THE PERFORATION. THE PERFORATION WAS SEALED; HOWEVER, THERE WAS A LOSS OF THE SIDE BRANCH. IT WAS NOTED THAT THE PROFILE OF THE DEVICE MADE ADVANCEMENT CHALLENGING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 699123

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention