BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 4182273 · Received October 17, 2014

    Report

    Report Number
    2024168-2014-06779
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 24, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. THE GRAFTMASTER WAS IMPLANTED SUCCESSFULLY; HOWEVER, THE DEVICE WAS REPORTEDLY USED AFTER EXPIRATION. REVIEW OF THE LABELS ATTACHED TO THE DEVICE HISTORY RECORD FOR THIS LOT WAS CONDUCTED AND THE LABEL INDICATED AN EXPIRATION DATE (USE BY DATE) OF 31-AUGUST-2014 WHICH IS BASED ON THE SHELF LIFE EXTENSION OF 6 MONTHS FROM THE ORIGINAL EXPIRATION DATE 28-FEBRUARY-2014, AND THE IMPLANT PROCEDURE DATE IS (B)(6) 2014 WHICH IS APPROXIMATELY (B)(6) DAYS POST EXPIRATION, THUS CONFIRMING THE COMPLAINT. IT SHOULD BE NOTED THAT THE OTW GRAFTMASTER INSTRUCTIONS FOR USE (IFU) STATES THAT IT IS NOT RECOMMENDED THAT THE PRODUCT BE USED AFTER THE USE BEFORE DATE. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR USE PAST EXPIRATION REPORTED FROM THIS LOT. 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 DURING A PROCEDURE TO TREAT THE RIGHT CORONARY ARTERY, A PERFORATION OCCURRED WHICH REQUIRED THE USE OF A GRAFTMASTER STENT. TWO GRAFTMASTER STENTS (4.0 X 16 MM, 4.0 X 19 MM) WERE IMPLANTED AND THE PERFORATION WAS SEALED SUCCESSFULLY, WITH EXCELLENT RESULTS. AFTER THE PROCEDURE, IT WAS OBSERVED THAT THE IMPLANTED 4.0 X 16 MM GRAFTMASTER STENT WAS EXPIRED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661992 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 713071

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR STENT: 4.0 X 19 MM GRAFTMASTER