BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 3130749 · Received May 24, 2013

    Report

    Report Number
    2024168-2013-03289
    Event Type
    Death
    Date Received
    May 24, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 30, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). USE AFTER EXPIRATION. THE STENT REMAINS IN THE ANATOMY; IT IS INDICATED THAT THE STENT DELIVERY SYSTEM (SDS) 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. THE DEVICE LABEL INDICATED AN EXPIRATION DATE (USE BY) OF 31-JANUARY-2013 AND THE IMPLANT PROCEDURE DATE WAS (B)(6) 2013 WHICH IS POST EXPIRATION. IT SHOULD BE NOTED THAT THE OTW GRAFTMASTER INSTRUCTIONS FOR USE (IFU) STATES, IN THE INSPECTION PRIOR TO USE SECTION, 9.1) THAT IT IS NOT RECOMMENDED THAT THE PRODUCT BE USED AFTER THE USE BEFORE DATE. IN THIS CASE, IT IS UNKNOWN IF THE USE AFTER EXPIRATION CONTRIBUTED TO THE REPORTED EVENT. 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 SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GRAFTMASTER (GM) STENT WAS USED TO TREAT A PERFORATION THAT OCCURRED IN THE RIGHT CORONARY ARTERY (RCA) WITH THE USE OF A NON-ABBOTT DEVICE; THE 3.5 X 19 MM GM WAS IMPLANTED AT 16 ATMOSPHERE (ATM) BUT THE PERFORATION WAS NOT SEALED. IT WAS NOTED THAT THE EASE OF HANDLING WAS "POOR"; HOWEVER, THE GM DID NOT CAUSE ADDITIONAL COMPLICATIONS OR AN ADVERSE EVENT. A SECOND 3.0 X 16 MM GM WAS IMPLANTED, BUT THE PERFORATION WAS NOTED AS NOT SEALED AND THE EASE OF HANDLING WAS NOTED AS "WAS THE LEAST DELIVERABLE PRODUCT USED IN THE CASE", HOWEVER, IT DID NOT CAUSE ADDITIONAL COMPLICATIONS OR ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232849 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 640914

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death