BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGIC WALLSTENT STENT SYSTEM

    MDR report key: 2003212 · Received February 28, 2011

    Report

    Report Number
    2134265-2011-00354
    Event Type
    Injury
    Date Received
    February 28, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P980009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IF IMPLANTED, GIVE DATE: (B)(6). AGE AT TIME OF EVENT - 18 YEARS OR OLDER. 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

    SAME CASE AS MDR ID#2134265-2011-00355. IT WAS REPORTED THAT FOLLOWING A PERIPHERAL STENTING TREATMENT PROCEDURE VESSEL OCCLUSION AND STENT DAMAGE OCCURRED. TWO MAGIC WALLSTENT D. 5.5, L. LONG (60) STENTS WERE IMPLANTED IN THE MID TO DISTAL RIGHT ANTERIOR TIBIAL ARTERY. 10 YEARS LATER, THE PATIENT EXPERIENCED FOOT DISCOLORATION AND CLAUDICATION SYMPTOMS. ANGIOGRAPHY REVEALED THE PREVIOUSLY IMPLANTED STENTS APPEARED "COMPLETELY OCCLUDED" "FRACTURED" AND "CRUSHED" IN THE MID SEGMENT. THE FLOW AROUND THE STENTS WAS NOTED TO BE "SLOW"; HOWEVER, THE PATIENT HAS NOT REQUIRED INTERVENTION TO DATE. TREATMENT OPTIONS ARE BEING CONSIDERED AND THE PATIENT WILL BE RE-EVALUATED IN THE FUTURE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGIC WALLSTENT STENT SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H965MAG645320 9C1909

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MAGIC WALLSTENT D. 5.5, L. LONG (60)