BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 3122901 · Received May 21, 2013

    Report

    Report Number
    2024168-2013-03211
    Event Type
    Death
    Date Received
    May 21, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 26, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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. IT SHOULD BE NOTED THAT DEATH AND HEMORRHAGE, ARE LISTED IN THE OTW GRAFTMASTER INSTRUCTIONS FOR USE (IFU) AS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF JOSTENT CORONARY STENT GRAFT PROCEDURES. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY. THE JOSTENT GRAFTMASTER IS BEING FILED UNDER SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A BRACHIAL ARTERY ACCESS APPROACH THE GRAFTMASTER STENT WAS USED TO TREAT A PERFORATION THAT OCCURRED IN THE RIGHT CORONARY ARTERY (RCA) WITH THE USE OF A NON-ABBOTT DEVICE, HOWEVER, IT COULD NOT ADVANCE DUE TO THE EXTREME TORTUOSITY OF THE VESSEL. IT WAS NOTED THAT AT 3.5 X 19 MM AND A 3.0 X 16 MM GRAFTMASTER STENT WERE ATTEMPTED BUT NEITHER COULD CROSS THE TORTUOUS LESION. THE PATIENT WAS IMMEDIATELY TRANSFERRED TO SURGERY FOR OPEN HEART INTERVENTION. IT WAS REPORTED THAT THE PATIENT COULD NOT BE WEANED OFF THE INTRA-AORTIC BALLOON PUMP (IABP) AND SUBSEQUENTLY EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225070 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 719240

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death OTHER: INTRA-AORTIC BALLOON PUMP (IABP)