BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 12712376 · Received October 28, 2021

    Report

    Report Number
    2024168-2021-09696
    Event Type
    Injury
    Date Received
    October 28, 2021
    Date of Event
    October 1, 2021
    Report Date
    October 28, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MAF
    UDI-DI
    08717648176364
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE REPORTED PATIENT EFFECT OF DEATH, AS LISTED IN THE GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM, INSTRUCTIONS FOR USE (IFU), IS A KNOWN PATIENT EFFECT THAT MAY BE ASSOCIATED WITH USE OF A CORONARY STENT IN NATIVE CORONARY ARTERIES. THE PATIENT EXPIRED TWO DAYS POST PROCEDURE OF MULTIPLE ORGAN SYSTEM FAILURE DUE TO DECLINING HEALTH. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE SUBSEQUENT TREATMENTS APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT 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 PATIENT PRESENTED IN DECLINING HEALTH WITH A FREE PERFORATION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.8X26MM GRAFTMASTER COVERED STENT WAS ADVANCED BUT DUE TO THE CALCIFIED AND DIFFICULT ANATOMY, AND INTERACTION WITH A PREVIOUSLY IMPLANTED STENT, THE GRAFTMASTER COVERED STENT DISLODGED FROM THE DELIVERY SYSTEM AND WAS EMBEDDED IN THE CORONARY ARTERY. SUBSEQUENTLY, THE PREVIOUSLY PLACED STENTS WERE RE-DILATED WITH A LARGER BALLOON AT HIGHER PRESSURES, AND A GUIDELINER WAS USED TO SUCCESSFULLY DELIVER A 3.5X26MM GRAFTMASTER COVERED STENT WHICH SEALED THE PERFORATION. THE PATIENT EXPIRED TWO DAYS POST PROCEDURE OF MULTIPLE ORGAN SYSTEM FAILURE DUE TO DECLINING HEALTH. PER THE PHYSICIAN, THE GRAFTMASTER STENTS DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DECLINING HEALTH OR DEATH. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1611757 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT DELIVERY SYSTEM MAF ABBOTT VASCULAR 1012580-26 1052541 08717648176364

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention