BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT VASCULAR STENT

    MDR report key: 4265580 · Received November 18, 2014

    Report

    Report Number
    9681442-2014-00141
    Event Type
    Injury
    Date Received
    November 18, 2014
    Date of Event
    September 16, 2014
    Report Date
    October 21, 2014
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THIS PRODUCT IS NOT SOLD IN THE U.S., THIS EVENT IS BEING REPORTED UNDER REGULATION 21CFR PART 803 AS IT INVOLVES A SIMILAR DEVICE TO A PMA APPROVED DEVICE SOLD IN THE U.S. UNDER #P070014. AS NEITHER THE PRODUCT CATALOG NUMBER NOR THE LOT NUMBER OF THE SUBJECT DEVICE HAS BEEN PROVIDED, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VASCULAR STENTING PROCEDURE OF THE LEFT SFA, THE VASCULAR STENT ELONGATED DURING POST-DILATION WITH A PTA BALLOON. THE ELONGATED STENT WAS DILATED ONCE MORE WITH A NEW BALLOON IN ORDER TO AVOID ANY STRUT MISPLACEMENT INSIDE THE VESSEL LUMEN. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746293 LIFESTENT VASCULAR STENT VASCULAR STENT NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention