BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-LUMINEXX VASCULAR STENT

    MDR report key: 5595735 · Received April 21, 2016

    Report

    Report Number
    9681442-2016-00114
    Event Type
    Injury
    Date Received
    April 21, 2016
    Report Date
    March 23, 2016
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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 OR IMAGE WAS RETURNED FOR EVALUATION. AS NO DETAILED EVENT INFORMATION WAS PROVIDED, AN ALLEGED DEVICE DEFICIENCY COULD NOT BE DETERMINED AND THE REPORTED EVENT COULD NOT BE REPRODUCED. THEREFORE, A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE IFU SUPPLIED WITH THIS PRODUCT SUFFICIENTLY DESCRIBES THE CORRECT APPLICATION OF THE DEVICE. FURTHERMORE, THE IFU INDICATES THAT THE BARD E-LUMINEXX VASCULAR STENT IS INTENDED FOR USE IN THE ILIAC AND FEMORAL ARTERIES. THE INDICATIONS ARE AS FOLLOWS: RESIDUAL STENOSIS WITH IMPAIRED PERFUSION (PRESSURE GRADIENT) FOLLOWING BALLOON DILATATION, ESPECIALLY IN STAGES III AND IV ACCORDING TO FONTAINE. DISSECTION. DETACHED ARTERIOSCLEROTIC PLAQUE MATERIAL AND LUMINAL OBSTRUCTION FOLLOWING BALLOON DILATATION. OCCLUSION AFTER THROMBOLYSIS OR AFTER ASPIRATION AND BEFORE DILATATION. RESTENOSIS OR REOCCLUSION. 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 # P080007.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT REQUIRED AN OPEN GRAFT INTERVENTION. AS REPORTED, THE CASE HAPPENED IN (B)(6) 2015. IT IS UNKNOWN IF THE EVENT WAS CAUSED BY A DEFICIENCY OF THE STENT. THIS IS THE SAME PATIENT AS REPORTED IN MEDWATCH REPORT # 9681442-2016-00115.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251795 E-LUMINEXX VASCULAR STENT VASCULAR STENT NIO ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANXA3525

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention