BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2801626 · Received October 23, 2012

    Report

    Report Number
    2024168-2012-06681
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    September 23, 2012
    Report Date
    September 28, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. (B)(4) - USE AFTER EXPIRATION. THE STENT REMAINS IN THE ANATOMY. IT IS INDICATED THAT THE STENT DELIVERY SYSTEM 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 THE OTW GRAFTMASTER INSTRUCTIONS FOR USE (IFU) STATES TO CAREFULLY INSPECT THE STERILE PACKAGE BEFORE OPENING. IT IS NOT RECOMMENDED THAT THE PRODUCT BE USED AFTER THE USE BEFORE DATE. 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 THAT THE GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS USED TO TREAT A PERFORATION OF THE SAPHENEOUS VEIN GRAFT OF THE RIGHT CORONARY ARTERY (RCA) THAT OCCURRED WITH THE USE OF A NON-ABBOTT DEVICE. THE GRAFTMASTER SDS WAS ADVANCED TO TREAT THE PERFORATION AND WAS DEPLOYED BUT DID NOT IMMEDIATELY SEAL THE PERFORATION AS DYE EXTRAVAZATION WAS SEEN; POST STENT DEPLOYMENT BALLOON EXPANSION WAS USED SUCCESSFULLY. AN ECHOCARDIOGRAM WAS PERFORMED AND A INTRAAORTIC BALLOON PUMP WAS PLACED; NO DYE EXTRAVAZATION WAS NOTED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THE PATIENT WAS DISCHARGED 5 DAYS POST PROCEDURE. ALL REQUESTED INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 607716

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention OTHER: INTRAAORTIC BALLOON PUMP