BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT ILIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

    MDR report key: 2020785 · Received March 16, 2011

    Report

    Report Number
    2134265-2011-01010
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P940019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). 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 STENTING TREATMENT PROCEDURE, THE DEPLOYED STENT APPEARED LONGER THAN ANTICIPATED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS, MODERATELY CALCIFIED, 7MM IN DIAMETER, LEFT COMMON TO EXTERNAL ILIAC ARTERIES. THE LESION WAS PRE-DILATED. THIS 6F 8X47X75 REDUCED PROFILE WALLSTENT WAS DEPLOYED IN THE LESION WITHOUT DIFFICULTIES AND POST-DILATED. THE STENT WAS FULLY EXPANDED AND WELL APPOSED. UPON DEPLOYMENT, IT WAS NOTED BY THE PHYSICIAN THAT THE STENT APPEARED TO BE 100MM LONG UNDER ANGIOGRAPHY. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. BLOOD FLOW WAS CONFIRMED TO THE HYPOGASTRIC ARTERY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    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 M001712200 14068133

    Patients

    Seq Age Sex Outcome Treatment
    1