BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 3942528 · Received July 17, 2014

    Report

    Report Number
    2024168-2014-04608
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 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). 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 OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR FAILURE TO ADVANCE FROM THIS LOT. 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 MILDLY CALCIFIED, MILDLY TORTUOUS, 80% STENOSED, MID CIRCUMFLEX ARTERY DURING PRE-DILATATION WITH A 3.0 X 15 MM UNSPECIFIED BALLOON DILATATION CATHETER (BDC) RESISTANCE FORCE AND BALLOON RUPTURE OCCURRED AND VESSEL PERFORATION DAMAGE WAS NOTED. THE BDC WAS REMOVED AND A 2.8 X 16 MM GRAFTMASTER WAS ADVANCED BUT COULD NOT CROSS THE DAMAGED VESSEL. THE PATIENT WAS TRANSFERRED TO SURGERY FOR INTERVENTION OF THE DAMAGED VESSEL. ALTHOUGH THERE WAS A REPORTED DELAY IN THE PROCEDURE THERE WAS NO CLINICALLY SIGNIFICANT INTERVENTION RELATED TO THE GRAFTMASTER OR ANY REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418050 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 3103041

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention