BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1812326 · Received August 24, 2010

    Report

    Report Number
    2134265-2010-03785
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED ASYSTOLE AND STENT THROMBOSIS. THE PATIENT PRESENTED FOR THE INDEX PROCEDURE DUE TO UNSTABLE ANGINA, ST DEPRESSIONS, AND A POSITIVE NUCLEAR STRESS TEST WHICH SHOWED ANTERIOR WALL ISCHEMIA. IT IS REPORTED THAT THE PATIENT TOOK 81MG OF ASA PRIOR TO ADMIT, THE DAY BEFORE THE INDEX PROCEDURE. PERIPROCEDURAL MEDICATIONS INCLUDED ANGIOMAX 17ML, ANGIOMAX GGT 40ML/HOUR, AND POST STENT DEPLOYMENT, BUT PRIOR TO EVENT MEDICATIONS INCLUDED ASA 325MG AND PLAVIX 600MG. THE 80% STENOSED AND 14MM LONG DE NOVO TARGET LESION WAS LOCATED IN THE NON CALCIFIED MID RIGHT CORONARY ARTERY (RCA) WITH TIMI-3 FLOW. THE DISTAL PORTION OF THE VESSEL WAS REPORTED TO HAVE MODERATE DIFFUSE LUMINAL IRREGULARITIES. IT WAS TREATED WITH PREDILATION USING A 2.5X15MM NON BSC BALLOON CATHETER AT 8ATM FOR 9 SECONDS. THE 3.5X16MM VERIFLEX STENT DELIVERY SYSTEM (SDS) WAS THEN ADVANCED AND DEPLOYED AT 15ATM FOR 12 SECONDS WITH NO POST DILATION RESULTING IN 0% RESIDUAL STENOSIS AND TIMI-3 FLOW WAS MAINTAINED. POST INDEX INTRAVASCULAR ULTRASOUND (IVUS) INDICATED FULL STENT APPOSITION. IT WAS REPORTED THAT THE MIDDLE RIGHT VENTRICULAR (RV) BRANCH WAS COMPROMISED WITH STENT DEPLOYMENT, FOR WHICH THE PATIENT WAS PUT ON A TRIDIL INFUSION OVERNIGHT IN AN ATTEMPT TO REESTABLISH FLOW IN THE SMALL RV BRANCH. ONE HOUR AND 50 MINUTES POST STENT DEPLOYMENT, THE PATIENT DEVELOPED ASYSTOLE. CPR WAS STARTED AND 1MG IV EPINEPHRINE WAS GIVEN. THEN VENTRICULAR FIBRILLATION DEVELOPED, AND ELECTRIC SHOCK WAS DELIVERED AT 360J, AND THE RHYTHM CHANGED TO SINUS TACHYCARDIA. THE PATIENT WAS PLACED ON NON-REBREATHER OXYGEN SET AT 100% AND WAS RETURNED TO THE CATH LAB WHERE REOPRO IC 29.3MG, REOPRO GTT 10MCG/MIN, ALONG WITH 4000 UNITS OF HEPARIN WERE ALL ADMINISTERED. CARDIAC CATHETERIZATION REVEALED STENT THROMBOSIS IN THE DISTAL PORTION OF THE PREVIOUSLY PLACED STENT IN THE MID RCA. IT WAS 100% OCCLUDED WITH TIMI-0 FLOW, 12MM IN LENGTH AND NON CALCIFIED. A NON-BSC THROMBUS EXTRACTION CATHETER WAS USED, FOLLOWED BY IVUS. A 3.5X12MM VERIFLEX STENT WAS DEPLOYED OVERLAPPING DISTALLY WITH THE PREVIOUSLY PLACED STENT AT 15ATM FOR 12 SECONDS FOLLOWED BY POST DILATION WITH THE SDS BALLOON AT 16ATM FOR 8 SECONDS. ADDITIONAL POST DILATION PERFORMED WITH A 4.0X12MM QUANTUM APEX NON COMPLIANT BALLOON AT 12ATM FOR 12 SECONDS AND 13ATM FOR 11 SECONDS RESULTING IN 0% RESIDUAL STENOSIS AND TIMI-3 FLOW. POST PROCEDURE IVUS INDICATED THAT THE STENTS WERE FULL APPOSED. THE PATIENT'S STATUS AFTER THE EVENT WAS REPORTED TO BE FINE AND WAS DISCHARGED HOME 2 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893416350 13015602

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R VOYAGER RX BALLOON 2.5X15MM