BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 15116799 · Received July 27, 2022

    Report

    Report Number
    2024168-2022-08251
    Event Type
    Injury
    Date Received
    July 27, 2022
    Date of Event
    July 8, 2022
    Report Date
    September 20, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL GRAFTMASTER STENT REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    A VISUAL AND DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED FAILURE TO ADVANCE COULD NOT BE EVALUATED AS THE EXACT ANATOMICAL CONDITIONS ENCOUNTERED BY THE DEVICE USED DURING THE PROCEDURE COULD NOT BE REPLICATED IN THE TEST LABORATORY. 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 REPORTED FAILURE TO ADVANCE APPEARS 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 OF THE DEVICE. D4: LOT NUMBER CHANGED FROM 1112341 TO 1062941.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A FREE PERFORATION WITH EXTRAVASATION IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.8X19MM RX GRAFTMASTER COVERED STENT FAILED TO CROSS DUE TO ANATOMY. A SECOND 2.8X19 RX GRAFTMASTER COVERED STENT WAS USED BUT ALSO FAILED TO CROSS DUE TO ANATOMY. BALLOON ANGIOPLASTY WAS PERFORMED TO SEAL THE PERFORATION. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116113 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT DELIVERY SYSTEM MAF ABBOTT VASCULAR 1062941

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other