BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT VASCULAR PERCLOSE PROGLIUDE

    MDR report key: 6072195 · Received October 31, 2016

    Report

    Report Number
    MW5065753
    Event Type
    Injury
    Date Received
    October 31, 2016
    Date of Event
    October 25, 2016
    Report Date
    October 31, 2016
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE PLANNED PVC ABLATION IN THE EP LAB ON (B)(6). HX OF NONISCHEMIC CARDIO MYOPATHY, STATUS POST ICD IMPLANT, WITH NORMALIZATION OF EF. HE CONTINUES TO HAVE CLASS III SYMPTOMS HF. A 9-FRENCH ACCESS IN THE R COMMON FEMORAL ARTERY WITH 2 PRE-CLOSE DEVICES DEPLOYED. UPON PULLING THE SHEATH AND SUTURING DOWN THE PRE-CLOSE DEVICES, THERE APPEARED TO BE INJURY TO THE FEM ARTERY GIVEN THE LACK OF DISTAL PULSES AND APPEARANCE OF A STRIP INTIMA PULLED OUT WITH ONE OF THESE SUTURES. HEMOSTASIS WAS ACHIEVED WITH MANUAL PRESSURE. AN ANGIOGRAM PERFORMED THROUGH A LEFT COMMON FEM ARTERY ACCESS IN THE ER LAB SHOWED A FLOW LIMITING DISSECTION WITH RECONSTITUTION OF THE FEM BIFURCATION. THE L COMMON FEM ARTERY SHEATH WAS LEFT IN PLACE. PT TO OPERATING ROOM. A SMALL ACUTE THROMBUS REMOVED. R FEM ARTERY CUTDOWN, THROMBECTOMY OF THE R FEM ARTERY FOLLOWED BY REPAIR WITH 8 MM RINGED HEPARIN-BONDED PTFE INTERPOSITION GRAFT FROM DISTAL EXTERNAL ILIAC TO THE FEM BIFURCATION, R LEG ANGIOGRAM. POSTOP PT MONITORED. DATES OF USE: (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717452 ABBOTT VASCULAR PERCLOSE PROGLIUDE ABBOTT VASCULAR PERCLOSE PROGLIUDE MGB ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R