BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 4192725 · Received October 22, 2014

    Report

    Report Number
    2024168-2014-06887
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY/REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE ADDITIONAL 4.0 X 18 MM XIENCE XPEDITION AND 4.0 X 16 MM GRAFTMASTER REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY. THE 4.0 X 18 MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND DEPLOYED. AFTER DEPLOYMENT, A DISTAL DISSECTION WAS OBSERVED. TWO NON-ABBOTT STENTS WERE PLACED TO TREAT THE DISSECTION, BUT IT WAS THEN NOTED THAT THE INITIAL DISTAL DISSECTION BECAME A PERFORATION. THE 3.5 X 16 MM GRAFTMASTER STENT WAS DEPLOYED FOR TREATMENT, BUT THE PERFORATION WAS NOT SEALED. THE 4.0 X 16 MM GRAFTMASTER STENT WAS ADVANCED, BUT FAILED TO CROSS DUE TO THE ANATOMY. A 2.8 X 16 MM GRAFTMASTER WAS THEN ADVANCED AND DEPLOYED, AND THE PERFORATION WAS SEALED SUCCESSFULLY. THE PATIENT HAD A GOOD OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671176 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 3061241

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention STENT: 4.0 X 18 MM XIENCE XPEDITION