BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 11304429 · Received February 9, 2021

    Report

    Report Number
    2024168-2021-01025
    Event Type
    Injury
    Date Received
    February 9, 2021
    Date of Event
    January 20, 2021
    Report Date
    February 9, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MAF
    UDI-DI
    08717648176340
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT-DEVICE INCOMPATIBILITY/DEVICE OPERATES DIFFERENTLY (FAILURE TO SEAL)/STENT GRAFT LEAK; HOWEVER, THE SUBSEQUENT TREATMENT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT PRESENTED WITH A LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY PERFORATION. A 2.8X16MM (1012580-16, 9032541) GRAFTMASTER STENT WAS SUCCESSFULLY IMPLANTED, HOWEVER, THE STENT FAILED TO SEAL THE PERFORATION. IT IS UNKNOWN IF THE FAILURE WAS DUE TO LEAKING OR IF THE PERFORATION WAS LARGER. COIL EMBOLIZATION WAS PERFORMED TO SUCCESSFULLY SEAL THE PERFORATION. THERE WAS NO OTHER ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201508 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT DELIVERY SYSTEM MAF ABBOTT VASCULAR 1012580-16 9032541 08717648176340

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention