BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 12960171 · Received December 8, 2021

    Report

    Report Number
    2024168-2021-11249
    Event Type
    Injury
    Date Received
    December 8, 2021
    Date of Event
    November 17, 2021
    Report Date
    January 19, 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.

    Additional Manufacturer Narrative · 0

    A VISUAL AND DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED FAILURE TO ADVANCE COULD NOT BE TESTED AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. 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 MANUFACTURE, DESIGN OR LABELING.B5: SUBSEQUENT TO THE INITIALLY FILED REPORT, IT WAS NOTED THE DEVICE WAS A 3.5X16 MM GRAFTMASTER AND NOT A 3.6X16 MM GRAFTMASTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 3.6X16 MM GRAFTMASTER COVERED STENT DID NOT CROSS TO TREAT THE PERFORATION IN THE HEAVILY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A 4.0X16 MM GRAFTMASTER COVERED STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIALLY FILED REPORT, IT WAS NOTED THE DEVICE WAS A 3.5X16 MM GRAFTMASTER. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1859514 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT DELIVERY SYSTEM MAF ABBOTT VASCULAR 0013041

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other