BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 4103231 · Received September 19, 2014

    Report

    Report Number
    2024168-2014-06073
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 25, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR STENT GRAFT LEAK OR DEVICE OPERATES DIFFERENTLY THAN EXPECTED REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE OTHER TWO GRAFTMASTERS REFERENCED ARE BEING FILED UNDER SEPARATE MANUFACTURING REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INTERVENTION IN THE CHRONICALLY TOTALLY OCCLUDED (CTO) RIGHT CORONARY ARTERY (RCA), A PERFORATION WAS CAUSED BY AN UNSPECIFIED STENT IMPLANT. THE 3.0X12MM, 4.0X12MM, AND 3.0X19MM GRAFTMASTER STENTS WERE SUCCESSFULLY DEPLOYED WITHOUT ISSUE; HOWEVER, THE PERFORATION WAS NOT SEALED (SLIGHT LEAK NOTED). NO ADDITIONAL TREATMENT WAS PERFORMED FOR THE PERFORATION. THE PATIENT WAS CONSIDERED TO BE DOING WELL AND WAS DISCHARGED. ADDITIONALLY, A COMMENT WAS MADE THAT THE PERFORMANCE OF THE OTW GRAFTMASTER IS POOR DUE TO A PERSONAL PREFERENCE OF THE PHYSICIAN, AS HE PREFERS RX SYSTEMS FOR ALL DEVICES. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582221 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 729521

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention STENT: GRAFTMASTER 4.0X12MM, 3.0X19MM