BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABBOTT VASCULAR GRAFTMASTER

    MDR report key: 7295711 · Received February 23, 2018

    Report

    Report Number
    MW5075481
    Event Type
    Death
    Date Received
    February 23, 2018
    Date of Event
    February 9, 2018
    Report Date
    February 20, 2018
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MAF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING A BALLOON DILATION A PERFORATION WAS NOTED. A 2.8 X 20 MM GRAFTMASTER WAS PLACED INTO THE PERFORATED PORTION. WHILE PUSHING THE GRAFTMASTER IT GOT STUCK INTO THE LAD MAIN AREA. THIS WAS VERY CALCIFIED AND SUBSEQUENTLY UNABLE TO PUSH DOWN. PULLED BACK TO PULL BACK THE BALLOON; HOWEVER, THE SHAFT BECAME DETACHED FROM THE STENT AND THE GRAFTMASTER STENT WAS STUCK IN THE LEFT MAIN LAD AREA. THERE WAS NO WAY TO TAKE THIS OUT AND PERFORATION CONTINUED TO BLEED. THE CT SURGERY TEAM WAS CONTACTED FOR ASSISTANCE. PROCEDURE: THE PATIENT UNDERWENT A REDO STERNOTOMY WITH RIGHT FEMORAL VENOUS CANNULATION, CORONARY ARTERY BYPASS USING MILD SYSTEMIC HYPOTHERMIA TO 34 DEGREES CENTIGRADE, WITH HYPOTHERMIC HYPERKALEMIC BLOOD CARDIOPLEGIC ARREST IN RETROGRADE AND ANTEGRADE FASHION.; AORTOTOMY AND EXPLORATION OF THE AORTIC ROOT AND REMOVAL OF FOREIGN BODY FROM LEFT MAIN, INCLUDING CATHETER AND UNDEPLOYED METAL SENT WITH CATHETER.; CORONARY BYPASS GRAFTING X 2 WITH VEIN GRAFT TO PERFORATED DIAGONAL, VEIN GRAFT TO THE POSTERIOR DESCENDING ARTERY, WITH ENDARTERECTOMY OF THE DIAGONAL BRANCH, AS WELL AS ENDARTERECTOMY OF THE POSTERIOR DESCENDING ARTERY. ON (B)(6) 2018 PATIENT EXHIBITED AGONAL RHYTHM IN SPITE OF ALL EFFORTS THE PATIENT EXPIRED AT 0604.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137269 ABBOTT VASCULAR GRAFTMASTER GRAFTMASTER CORONARY STENT GRAFT SYSTEM MAF ABBOTT VASCULAR REF 1012580-26 6090141

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death