BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 3903421 · Received June 30, 2014

    Report

    Report Number
    2024168-2014-04239
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF DISSECTION, AS LISTED IN THE GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM INSTRUCTIONS FOR USE (IFU), IS A KNOWN PATIENT EFFECT THAT MAY BE ASSOCIATED WITH USE OF A CORONARY STENT GRAFT SYSTEM. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROXIMAL PORTION OF THE SAPHENOUS VEIN BYPASS GRAFT TO THE DISTAL RIGHT MAIN CORONARY ARTERY HAD A SERIES OF SEVERE STENOSES WITH THE FIRST AND MOST SEVERE BEING 98-99% STENOSED. THERE WERE THREE AREAS OF ANEURYSMAL DILATATION; TWO ABBOTT GRAFTMASTER 4.8 X 19 MM COVERED STENTS WERE DEPLOYED WITH A VERY SLIGHT OVERLAP BETWEEN THESE TWO COVERED STENTS. EACH OF THE STENTS WAS DEPLOYED USING 18 ATMOSPHERE (ATM). THERE WAS CONCERN ABOUT A DISTAL EDGE DISSECTION INVOLVING THE FIRST DEPLOYED COVERED STENT, AND THEREFORE, AFTER REMOVING THE BALLOON DILATATION CATHETER THE PATIENT WAS GIVEN INTRACORONARY NITROGLYCERINE AND A 4.0 X 8 MM NON-ABBOTT DRUG-ELUTING STENT WAS INTRODUCED AND POSITIONED IN THE DISTAL PORTION ACROSS THE AREA OF CONCERN AT 18 ATM; THERE WAS A SLIGHT OVERLAP WITH THIS STENT AND THE PREVIOUSLY DEPLOYED COVERED STENT. ADDITIONALLY, EARLY IN THE PROCEDURE IT WAS NOTED THAT A 0.014 WHISPER J GUIDE WIRE WAS ATTEMPTED TO BE PLACED ACROSS THE STENOSIS BUT IT COULD NOT BE MANEUVERED PAST THE MOST PROXIMAL SEVER STENOSIS; THE GUIDE WIRE WAS REMOVED AND EXCHANGED FOR A 190 CM LONG 0.014 CROSS-IT J GUIDE WIRE WHICH AFTER DIFFICULTY WAS MANEUVERED ACROSS THE STENOSES. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379888 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 3102341

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention GUIDE WIRE: CROSS-IT J