BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 3061517 · Received April 16, 2013

    Report

    Report Number
    2024168-2013-02322
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 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). 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION OF A SAPHENOUS VEIN GRAFT TO THE RIGHT CORONARY ARTERY. AN UNKNOWN DEVICE CAUSED A PERFORATION AND A NON-ABBOTT STENT WAS USED IN AN ATTEMPT TO SEAL THE PERFORATION. IT WAS DECIDED TO TAKE THE PATIENT TO THE OPERATING ROOM FOR OPEN HEART SURGERY; HOWEVER, WHILE WAITING FOR THE OPERATING ROOM, IT WAS DECIDED TO TRY TO SEAL THE PERFORATION WITH A 3.5 X 16 MM GRAFTMASTER. THE GRAFTMASTER COULD NOT CROSS THE LESION SO THE PATIENT WAS TAKEN TO SURGERY WITHOUT SEALING THE PERFORATION. TWELVE HOURS POST SURGERY, THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163658 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 656719

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention