BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER

    MDR report key: 10146102 · Received June 11, 2020

    Report

    Report Number
    2024168-2020-04945
    Event Type
    Injury
    Date Received
    June 11, 2020
    Date of Event
    May 21, 2020
    Report Date
    June 11, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MAF
    UDI-DI
    08717648176357
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. 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 THE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A FREE PERFORATION IN THE CIRCUMFLEX CORONARY ARTERY. A 2.8X19MM RX GRAFTMASTER COVERED STENT DELIVERY SYSTEM FAILED TO CROSS DUE TO THE ANATOMY. A COIL WAS USED TO SEAL THE PERFORATION AND SUCCESSFULLY COMPLETE THE PROCEDURE. PER THE PHYSICIAN, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO COMPLICATIONS OR ADVERSE EVENTS, AND THERE WERE NO OTHER DEVICE ISSUES. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605598 GRAFTMASTER CORONARY STENT DELIVERY SYSTEM MAF ABBOTT VASCULAR 1012580-19 8120641 08717648176357

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention