BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 3171200 · Received June 14, 2013

    Report

    Report Number
    2024168-2013-03756
    Event Type
    Death
    Date Received
    June 14, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 22, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. 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. IT SHOULD BE NOTED THAT DEATH IS LISTED IN THE OTW GRAFTMASTER INSTRUCTIONS FOR USE AS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF JOSTENT CORONARY STENT GRAFT PROCEDURES. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY. THE JOSTENT GRAFTMASTER REFERENCED, IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED CIRCUMFLEX ARTERY. A ROTOBLADER WAS USED WHICH CAUSED A PERFORATION. TWO GRAFTMASTERS, 3.0 X 12 MM AND 3.0 X 19 MM, WERE IMPLANTED WHICH DID NOT COMPLETELY SEAL THE PERFORATION. A PERCARDIOCENTESIS WAS PERFORMED AND THE PATIENT WENT IN TO CARDIAC ARREST. CPR WAS PERFORMED AND THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271389 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 723409

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death