BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 4141097 · Received October 3, 2014

    Report

    Report Number
    2024168-2014-06427
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 10, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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/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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERFORATION OCCURRED IN THE LEFT ANTERIOR DESCENDING (LAD) WITH THE USE OF AN UNSPECIFIED DEVICE AND THE GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED FOR TREATMENT, HOWEVER, THE SDS WOULD NOT CROSS THE LESION AND WAS REMOVED WITHOUT REPORTED ISSUE. A DIFFERENT INTERVENTIONAL METHOD WAS USED TO TREAT THE PERFORATION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619341 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 3042441

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention