BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 11446002 · Received March 9, 2021

    Report

    Report Number
    2024168-2021-01862
    Event Type
    Malfunction
    Date Received
    March 9, 2021
    Date of Event
    March 3, 2021
    Report Date
    April 5, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MAF
    UDI-DI
    08717648176395
    PMA / PMN Number
    H000001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NAA2: CORRECTION.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUS MEDWATCH REPORT, THE ADDITIONAL INFORMATION WAS RECEIVED:IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT PRESENTED WITH A CORONARY ARTERY PERFORATION/DISSECTION. A 3.5X16MM GRAFTMASTER STENT WAS SUCCESSFULLY IMPLANTED IN THE OSTIAL CORONARY ARTERY, HOWEVER, THE STENT WAS IMPLANTED IN AN AREA THAT DID NOT FULLY COVER THE PERFORATION. THERE WAS NO DEVICE ISSUE, NO STENT LEAKING, AND NO MALFUNCTION REPORTED. PER PHYSICIAN, THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO COMPLICATIONS NOT ADVERSE EVENTS. THERE WAS NO COMPLAINT REGARDING THIS DEVICE.AS PREVIOUSLY REPORTED, ON (B)(6) 2021, AN EXPIRED 3.5X16MM GRAFTMASTER STENT (1012581-16, 8100341) WAS SUCCESSFULLY IMPLANTED, SEALING THE DISSECTION/PERFORATION.

    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 PRODUCT WAS USED AFTER EXPIRATION AS IT WAS REPORTED THE PROCEDURE OCCURRED ON (B)(6) 2021. THE EXPIRATION DATE OF THE PRODUCT IS IMPORTANT FOR STERILITY, EFFICACY, AND PERFORMANCE OF THE DEVICE. IT SHOULD BE NOTED THAT THE GRAFTMASTER RAPID EXCHANGE CORONARY STENT GRAFT SYSTEM, INSTRUCTIONS FOR USE STATES: NOTE THE PRODUCT USE BY DATE SPECIFIED ON THE PACKAGE. THE INVESTIGATION DETERMINED THE REPORTED DEVICE EXPIRATION ISSUE APPEARS TO BE RELATED TO USE ERROR. 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 ON (B)(6) 2021, THE PATIENT PRESENTED WITH A CORONARY ARTERY PERFORATION/DISSECTION. A GRAFTMASTER STENT (UNK PART / UNK LOT) WAS SUCCESSFULLY IMPLANTED, HOWEVER, THE STENT WAS IMPLANTED IN AN AREA THAT DID NOT FULLY COVER THE PERFORATION. THERE WAS NO DEVICE ISSUE, NO STENT LEAKING, AND NO MALFUNCTION REPORTED. THERE WAS NO COMPLAINT REGARDING THIS DEVICE. ON (B)(6) 2021, ANOTHER GRAFTMASTER STENT (1012581-16, 8100341) WAS SUCCESSFULLY IMPLANTED, SEALING THE DISSECTION/PERFORATION. REPORTEDLY, IT WAS UNKNOWN THAT THIS STENT WAS EXPIRED UNTIL AFTER IMPLANTATION. THERE WAS NO ADVERSE PATIENT SEQUELA NOTED. THERE WAS NO DEVICE MALFUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346570 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT DELIVERY SYSTEM MAF ABBOTT VASCULAR 1012581-16 8100341 08717648176395

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 1 GRAFTMASTER STENT