BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT VASCULAR STENT

    MDR report key: 4559172 · Received February 26, 2015

    Report

    Report Number
    9681442-2015-00012
    Event Type
    Injury
    Date Received
    February 26, 2015
    Date of Event
    January 21, 2015
    Report Date
    February 2, 2015
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THIS PROD IS NOT SOLD IN THE US, THIS EVENT IS BEING REPORTED UNDER REGULATION 21CFR PART 803 AS IT INVOLVES A SIMILAR DEVICE TO PMA APPROVED DEVICE SOLD IN THE US UNDER # P070014. THE LOT NUMBER HAS BEEN PROVIDED. THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VASCULAR STENT (150 MM LENGTH) FORESHORTENED TO 50 MM DURING DEPLOYMENT IN THE SFA. AN ADD'L STENT WAS USED TO COVER THE LESION COMPLETELY. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137709 LIFESTENT VASCULAR STENT VASCULAR STENT NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANXG3277

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention