BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 7336711 · Received March 13, 2018

    Report

    Report Number
    2024168-2018-01800
    Event Type
    Death
    Date Received
    March 13, 2018
    Date of Event
    February 18, 2018
    Report Date
    March 13, 2018
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    UDI-DI
    08717648176418
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES: GUIDE WIRE: 0.35 BENTSON WIRE, .035 STIFF ANGLED, .014 NITREX, .014 CHOICE PT, MAILMAN SUPER SUPPORT, GUIDE CATH: 5F VCF , SHEATH: 5F TERUMO, 5F DESTINATION, 6F DESTINATION, 6F ANSEL, STENT: 3.5X12MM REBEL BARE METAL STENT. 3.5X16MM GRAFTMASTER, OTHER: 2MMX1CM RUBY COIL SOFT (2X), 2MMX4CM RUBY COIL SOFT (2X), 3MMX5CM RUBY COIL SOFT. (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REPORTED PATIENT EFFECTS OF DEATH AND HEMORRHAGE ARE LISTED IN THE GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM DOMESTIC INSTRUCTIONS FOR USE (IFU) AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. IN ADDITION, IT WAS REPORTED THAT THE GRAFTMASTER WAS USED IN THE COMMON HEPATIC ARTERY. IT SHOULD BE NOTED THAT THE GRAFTMASTER RAPID EXCHANGE (RX) CORONARY STENT GRAFT SYSTEM DOMESTIC IFU 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. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED FAILURE TO SEAL THE PERFORATION. 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 ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE 3.5X16MM GRAFTMASTER COVERED STENT IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN CATH LAB IN HYPOVOLEMIC SHOCK DUE TO GASTROINTESTINAL BLEEDING AND BLEEDING RIGHT PROXIMAL HEPATIC ARTERY. AN ANGIOGRAM WAS PERFORMED AND COIL EMBOLIZATION AND IMPLANTATION OF A BARE METAL STENT WAS PERFORMED BUT BLEEDING CONTINUED. A 3.5X16MM GRAFTMASTER COVERED STENT WAS IMPLANTED IN THE COMMON HEPATIC ARTERY. DURING BALLOON REMOVAL, THE STENT STUCK TO THE BALLOON AND THE STENT MOVED FROM ITS ORIGINAL POSITION INTO THE MORE PROXIMAL COMMON HEPATIC ARTERY. AFTER SUCCESSFULLY REMOVING THE BALLOON FROM THE STENT, A SECOND 3.5X26MM GRAFTMASTER COVERED STENT WAS IMPLANTED OVERLAPPING THE FIRST GRAFTMASTER AND COVERING THE ORIGIN OF THE BLEEDING VESSEL. ONE MORE COIL WAS PLACED IN THE BLEEDING VESSEL. BLEEDING SLOWED SIGNIFICANTLY BUT WAS STILL PRESENT. THIS WAS FELT TO BE SECONDARY TO FLOW THROUGH THE MATERIAL OF THE GRAFTMASTER STENT. THE PROCEDURE ENDED WITH NO OBVIOUS VARICEAL BLEEDING. THE PATIENT WAS REFERRED TO SURGERY BUT WAS DETERMINED TO NOT BE A SURGICAL CANDIDATE. THE PATIENT CONTINUED IN SHOCK, DISSEMINATED INTRAVASCULAR COAGULATION (DIC), ONGOING BLEEDING, AND ACIDOSIS. THE PATIENT MADE DO NOT RESUSCITATE AND EXPIRED FROM DIC, SHOCK, UNCONTROLLED BLEEDING AND PERFORATED DUODENAL ULCER. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179435 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 6111641 08717648176418

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death