BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 3092101 · Received May 3, 2013

    Report

    Report Number
    2024168-2013-02737
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 6, 2013
    Report Date
    April 15, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PRESENTED WITH A FREE PERFORATION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. TO TREAT THE PERFORATION, A 3.5 X 16 JOSTENT GRAFTMASTER COVERED STENT SYSTEM WAS ADVANCED AND DEPLOYED AT 12 ATMOSPHERES HELD FOR 8 SECONDS AT THE PERFORATION SITE WITHOUT ISSUE. THE JOSTENT GRAFTMASTER COVERED STENT FAILED TO COMPLETELY SEAL THE PERFORATION AND BLEEDING PERSISTED AND CAUSED ISCHEMIA. THE PATIENT WAS TRANSFERRED TO CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY TO TREAT THE VESSEL. THE VESSEL WAS TREATED VIA CABG AT ANOTHER HOSPITAL SITE. THERE WERE NO ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194090 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 705570

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R| S