BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT ILIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

    MDR report key: 2130324 · Received June 16, 2011

    Report

    Report Number
    2134265-2011-02514
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 25, 2011
    Report Date
    May 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P940019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE PARTIAL DEPLOYMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT BRACHIAL ARTERY AND IN AN UNSPECIFIED VESSEL LOCATED RIGHT BELOW THE PATIENT'S KNEE. THE 100% STENOSED LESION, APPROXIMATELY 12CM IN LENGTH TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATE TO SEVERELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). A 6F, 105CM, NON-BSC SHEATH WAS INSERTED THROUGH THE RIGHT BRACHIAL ACCESS SITE. A NON-BSC GUIDE WIRE CROSSED THE LESION VIA THE RIGHT BRACHIAL ACCESS SITE. THE LESION WAS PRE DILATED WITH A 3-20 WANDA BALLOON CATHETER THAT WAS INFLATED "SEVERAL" TIMES FROM NOMINAL TO RATED BURST PRESSURE. THE RESIDUAL STENOSIS WAS NOTED TO BE 100%. A 4MM WANDA BALLOON CATHETER WAS THEN INFLATED TO AN UNKNOWN NUMBER OF TIMES FROM NOMINAL TO RATED BURST PRESSURE TO TREAT THE LESION. THE LESION WAS ALSO DILATED WITH A 6MM WANDA BALLOON CATHETER THAT WAS INFLATED AN UNKNOWN NUMBER OF TIMES FROM NOMINAL TO RATED BURST PRESSURE. A 10-20 WALLSTENT WAS IMPLANTED IN THE "MOSTLY STENOSED PROXIMAL LESION" BUT DID NOT EXPAND FULLY. POST DILATION WITH A 8MM WANDA BALLOON CATHETER WAS PERFORMED. THE 8MM WANDA WAS INFLATED " A COUPLE OF TIMES" TO UNKNOWN ATMS. THE PHYSICIAN THEN ATTEMPTED TO CROSS A 10X69X135 ILIAC 6F UNISTEP PLUS STENT DELIVERY SYSTEM (SDS); HOWEVER, WHILE ATTEMPTING TO ADVANCE THE DEVICE THROUGH THE PREVIOUSLY IMPLANTED WALLSTENT, THE SHAFT OF THE 10X69X135 WALLSTENT KINKED. RESISTANCE WAS ENCOUNTERED AT AN UNKNOWN TIME. THE PHYSICIAN COMMENTED THAT THE "FIRSTLY IMPLANTED STENT COULD HAVE BEEN RECOILED". THE PHYSICIAN THEN ATTEMPTED TO USE THE OTHER ACCESS SITE. AN UNSPECIFIED 4F SHEATH HAD BEEN PLACED IN THE BEHIND THE KNEE ACCESS SITE THAT WAS EXCHANGED TO A 6F, 11CM, NON-BSC SHEATH. A 75CM WALLSTENT WAS IMPLANTED IN THE LESION. POST DILATION WAS PERFORMED WITH AN 8MM WANDA BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS OCCURRED AND PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT ILIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY M001712330 12859493

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH, PARENT 6F 105CM| BALLOON CATHETER, 3-20 WANDA| GUIDE WIRE, RADIFOCUS| BALLOON CATHETER, 4MM WANDA| BALLOON CATHETER, 6MM WANDA