BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT VASCULAR STENT

    MDR report key: 3890822 · Received June 4, 2014

    Report

    Report Number
    9681442-2014-00092
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    April 26, 2014
    Report Date
    May 8, 2014
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THIS PRODUCT IS NOT SOLD IN THE U.S., THIS EVENT IS BEING REPORTED UNDER REGULATION 21 CFR PART 803 AS IT INVOLVES A SIMILAR DEVICE TO A PMA APPROVED DEVICE SOLD ON THE U.S. UNDER # (B)(4). THE LOT HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THERE IS NO INDICATION FOR A MANUFACTURING-RELATED FAILURE. AS PART OF ALL COMPLAINT INVESTIGATIONS, AN ATTEMPT WAS MADE TO EVALUATE THE SUBJECT DEVICE AS WELL AS THE DEVICE USAGE IN THIS CASE, NO SAMPLE WAS RETURNED. BASED ON THE IMAGE PROVIDED, A STENT FRACTURE COULD NOT BE CONFIRMED. THE PROXIMAL STENT SHOWS A NARROWED AREA WHICH MAY HAVE BEEN CAUSED BY CALCIFICATION. AS THE STENT STRUT STRUCTURE IS NOT VISIBLE IN DETAIL DUE TO THE POOR RESOLUTION OF THE IMAGE, AN ASSESSMENT COULD NOT BE MADE. POTENTIAL FACTORS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT HAVE BEEN CONSIDERED. PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS HAVE BEEN REVIEWED. AN IRREGULAR STENT PLACEMENT MAY LEAD OR CONTRIBUTE TO A SUBSEQUENT STENT FRACTURE. AN INADVERTENT MOVEMENT OF THE HAND OR INCORRECT HOLDING OF THE DELIVERY SYSTEM DURING STENT RELEASE, AN INSUFFICIENT PRE OR POST-DILATATION AS WELL AS HIGHLY CALCIFIED VESSELS, THE PT'S CONDITION OR THE VESSEL ANATOMY MAY RESULT IN AN STENT IRREGULAR PLACEMENT. IN THIS CASE, THE VESSEL WAS REPORTED TO BE MORE THAN 75% STENOSED. BASED ON THE INFO AVAILABLE, A DEFINITE ROOT CAUSE FOR THE EVENT REPORTED COULD NOT BE DETERMINED. THE IFU SUPPLIED WITH THIS PRODUCT SUFFICIENTLY DESCRIBES THE CORRECT APPLICATION OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROXIMAL STENT OF TWO VASCULAR STENTS THAT WERE PLACED IN OVERLAPPING TECHNIQUE WAS FOUND TO BE RETURNED AND DEFORMED TWO DAYS POST PLACEMENT. THE PT FELT PAIN AND THE VESSEL WAS FOUND TO BE RE-OCCLUDED. A THROMBOLYTIC TREATMENT WAS DONE. AN ADDITIONAL PROCEDURE WILL BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326923 LIFESTENT VASCULAR STENT VASCULAR STENT NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANWK3016

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention