BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 3951057 · Received July 22, 2014

    Report

    Report Number
    2024168-2014-04695
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT: GUIDE WIRE: ASAHI FIELDER. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION - IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS. SUBSEQUENT INFORMATION REVEALED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A RADIAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE PROXIMAL TO MID 100% IN-STENT RESTENOSIS OF THE MID RIGHT CORONARY ARTERY (RCA) AN ASAHI FIELDER FC GUIDE WIRE WAS LOADED IN THE NON-ABBOTT MICROCATHETER AND USED FOR ANGIOPLASTY OF THE RCA AND POSTERIOR DESCENDING ARTERY (PDA). WHILE ATTEMPTING TO WIRE THE POSTERIOR LATERAL (PL) BRANCH A PERFORATION WAS NOTED IN THE DISTAL RCA. THE GRAFTMASTER COVERED STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT FAILED TO CROSS THE LESION. ANGIOPLASTY WAS PERFORMED TO THE RCA USING A 3.0 X 30 MM NON-ABBOTT BALLOON DILATATION CATHETER AND A 2.5 X 18 MM MULTILINK 8 STENT WAS DEPLOYED AT THE DISTAL RCA. IT WAS NOTED USING ECHOCARDIOGRAPHY THAT A SMALL PERICARDIAL EFFUSION OF THE POSTERIOR REMAINED. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT WAS SUBSEQUENTLY DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427642 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 3110641

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention