BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 12673249 · Received October 21, 2021

    Report

    Report Number
    2024168-2021-09465
    Event Type
    Injury
    Date Received
    October 21, 2021
    Date of Event
    September 29, 2021
    Report Date
    October 21, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MAF
    UDI-DI
    08717648176401
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 SIMILAR INCIDENTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED FAILURE TO ADVANCE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN A SAPHENOUS VEIN GRAFT IN THE RIGHT CORONARY ARTERY (SGV). THE 3.5X19MM GRAFTMASTER RX FAILED TO CROSS DUE TO INTERACTION WITH A PREVIOUS IMPLANTED STENT AT THE PROXIMAL ANASTOMOSIS OF THE SGV. ANOTHER UNSPECIFIED GRAFTMASTER RX WAS USED TO SUCCESSFULLY SEAL THE PERFORATION. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1570829 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT DELIVERY SYSTEM MAF ABBOTT VASCULAR 1012581-19 0112741 08717648176401

    Patients

    Seq Age Sex Outcome Treatment
    1 Other