BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 4182869 · Received October 17, 2014

    Report

    Report Number
    2024168-2014-06806
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    May 22, 2014
    Report Date
    September 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
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INCORRECT ANATOMY AND INDICATION FOR USE. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF ISCHEMIA IS A KNOWN OBSERVED AND POTENTIAL PATIENT EFFECT AS LISTED IN THE GRAFTMASTER CORONARY STENT GRAFT SYSTEM INSTRUCTIONS FOR USE. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING. REPORTEDLY, THE PROCEDURE WAS TO TREAT THE POPLITEAL ARTERY AT THE KNEE JOINT INTO THE UPPER POSTERIOR TIBIAL ARTERY AND NOT USED TO TREAT A PERFORATION. IT SHOULD BE NOTED THE GRAFTMASTER CORONARY STENT GRAFT SYSTEM INSTRUCTIONS FOR USE STATES: THE GRAFTMASTER RX IS INDICATED FOR USE IN THE TREATMENT OF FREE PERFORATIONS, DEFINED AS FREE CONTRAST EXTRAVASATION INTO THE PERICARDIUM, IN NATIVE CORONARY VESSELS OR SAPHENOUS VEIN BYPASS GRAFTS. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST ATHERECTOMY, PROLONGED BALLOON INSUFFLATION WAS PERFORMED USING A 2.5 MM DIAMETER BALLOON ACROSS THE ENTIRE AREA OF ATHERECTOMY WHICH WAS FROM THE POPLITEAL ARTERY AT THE KNEE JOINT INTO THE UPPER POSTERIOR TIBIAL ARTERY. THREE AND FIVE MINUTE INFLATIONS WERE PERFORMED WITH FULL ANTICOAGULATION, BUT DESPITE THIS, THERE WAS A PERSISTENT, HIGH-FLOW ARTERIOVENOUS (AV) FISTULA WHICH WAS COMPROMISING DISTAL FLOW INTO THE LEG. A 2.8X19 MM GRAFTMASTER COVERED STENT GRAFT WAS DEPLOYED IN THE TIBIOPERONEAL TRUNK AND FULLY INSUFFLATED. DESPITE THIS, THERE WAS PERSISTENT AV FISTULA FORMATION WHICH APPEARED TO ORIGINATE FROM JUST BELOW THE STENT-GRAFT. ALTHOUGH THE FIRST STENT-GRAFT HAD IMPROVED THE AV FISTULA, THERE WAS STILL PERSISTENT FLOW THAT WAS COMPROMISING DISTAL ARTERIAL FLOW IN THE FOOT. A SECOND 2.8X19 MM GRAFTMASTER COVERED STENT GRAFT WAS PLACED AND OVERLAPPED IN THE TIBIOPERONEAL TRUNK, SLIGHTLY OVERLAPPED WITH THE FIRST 2.8X19 MM GRAFTMASTER STENT GRAFT AND DEPLOYED. AGAIN FULL INSUFFLATION OF THE BALLOON WAS ACHIEVED AND FOLLOWING PLACEMENT OF THE SECOND GRAFTMASTER STENT GRAFT, THERE WAS MARKED DECREASED FLOW IN THE AV FISTULA AND MARKEDLY IMPROVED FLOW DOWN THE LEG. THE COMPLETION ANGIOGRAM DEMONSTRATED THAT THE POPLITEAL ARTERY, TIBIOPERONEAL TRUNK AND UPPER POSTERIOR TIBIAL ARTERY WERE WIDELY PATENT AND THERE WAS MINIMAL FLOW IN THE AV FISTULA. DOPPLER PULSE IN THE LEFT FOOT WAS TRIPHASIC AND THIS WAS CONSIDERED AN EXCELLENT ANGIOGRAPHIC RESULT. THE PATIENT TOLERATED THIS PROCEDURE WELL WITH NO EVIDENCE OF IMMEDIATE COMPLICATION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661676 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 3110741

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention