BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1901378 · Received November 17, 2010

    Report

    Report Number
    2134265-2010-05323
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: 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 DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A STENT DISLODGEMENT OCCURRED. THE 95% STENOSED LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MILDLY TORTUOUS MID SAPHENOUS VEIN GRAFT (SVG) THAT SUPPLIES THE LEFT CIRCUMFLEX (LCX). VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. AN 80 X 190 FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM WAS ADVANCED AND THE LESION WAS NOT PREDILATED. AS THE PHYSICIAN ATTEMPTED TO ADVANCE THE 4.5MM X 32MM VERIFLEX CORONARY STENT DELIVERY SYSTEM (SDS) ACROSS THE LESION RESISTANCE WAS ENCOUNTERED AND THE ATTEMPT WAS UNSUCCESSFUL. AS THE PHYSICIAN REMOVED THE VERIFLEX FROM THE LESION RESISTANCE WAS ENCOUNTERED AND IT WAS NOTED THAT THE VERIFLEX HAD DISLODGED FROM THE BALLOON, BUT REMAINED ON THE SDS. THE PHYSICIAN PULLED THE FILTERWIRE BACK IN AN ATTEMPT TO CATCH THE STENT AND WAS ABLE TO PULL THE STENT BACK TO THE DISTAL EDGE OF THE GUIDE CATHETER. THE FILTERWIRE TRAPPED THE VERIFLEX STENT AGAINST THE GUIDE CATHETER. THE PHYSICIAN REMOVED THE VERIFLEX STENT, SDS, FILTERWIRE AND GUIDE CATHETER AS A UNIT TO THE DISTAL EDGE OF THE INTRODUCER SHEATH LOCATED IN THE FEMORAL ARTERY. THE PHYSICIAN WAS UNABLE TO REMOVE THE VERIFLEX STENT THROUGH THE INTRODUCER SHEATH AND THEREFORE, COULD NOT COMPLETE THE PROCEDURE DUE TO THIS EVENT. THE PATIENT WAS TAKEN TO SURGERY TO HAVE THE VERIFLEX STENT REMOVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893432450

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention FILTERWIRE EZ EMOBLIC PROTECTION SYSTEM - 80 X 190