BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 4103249 · Received September 19, 2014

    Report

    Report Number
    2024168-2014-06075
    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). 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 THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY/REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE OTHER TWO GRAFTMASTERS 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
    582193 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 741627

    Patients

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