BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 6001632 · Received October 5, 2016

    Report

    Report Number
    2024168-2016-06688
    Event Type
    Injury
    Date Received
    October 5, 2016
    Date of Event
    September 14, 2016
    Report Date
    October 5, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    UDI-DI
    08717648176357
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER INCIDENTS. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED FAILURE TO SEAL THE PERFORATION. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN A SAPHENOUS VEIN GRAFT TO OBTUSE MARGINAL ARTERY. A 2.8X19MM GRAFTMASTER STENT SYSTEM WAS TAKEN TO THE PERFORATION, INFLATED TO 15 ATMOSPHERES (ATM), IMPLANTING THE STENT; HOWEVER, THE PERFORATION WAS NOT SEALED. THUS, A 3.5X16MM GRAFTMASTER STENT SYSTEM WAS TAKEN TO THE PERFORATION, INFLATED TO 16 ATM AND IMPLANTED SUCCESSFULLY, SEALING THE PERFORATION. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651231 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 6021941 08717648176357

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention