BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 10248729 · Received July 8, 2020

    Report

    Report Number
    2024168-2020-05583
    Event Type
    Death
    Date Received
    July 8, 2020
    Date of Event
    June 15, 2020
    Report Date
    August 20, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MAF
    UDI-DI
    08717648176487
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B2, B3: ESTIMATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECTS OF THROMBOSIS AND DEATH ARE LISTED IN THE GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM, INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS THAT MAY BE ASSOCIATED WITH USE OF A CORONARY STENT IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S), AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    ESTIMATED DATE. THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT PRESENTED WITH A RIGHT CORONARY ARTERY (RCA) PERFORATION/ARTERY RUPTURE WITH HEMOPERICARDIUM WITH CARDIAC TAMPONADE. THE PATIENT HAD BECOME HEMODYNAMICALLY UNSTABLE AND BALLOON ANGIOPLASTY WAS PERFORMED, HOWEVER, THE BLEEDING CONTINUED. A 4.50X19MM (1012583-19, 8120441) A GRAFTMASTER STENT WAS IMPLANTED WITHOUT A DEVICE ISSUE REPORTED, SEALING THE PERFORATION. ON AN UNSPECIFIED DATE, A POSSIBLE SUBACUTE STENT THROMBOSIS OCCURRED AND THE PATIENT HAD EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710906 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT DELIVERY SYSTEM MAF ABBOTT VASCULAR 1012583-19 8120441 08717648176487

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death