BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-LUMINEXX VASCULAR STENT

    MDR report key: 9516533 · Received December 24, 2019

    Report

    Report Number
    2020394-2019-05845
    Event Type
    Injury
    Date Received
    December 24, 2019
    Date of Event
    July 28, 2008
    Report Date
    December 24, 2019
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIO
    PMA / PMN Number
    P080007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A MANUFACTURING REVIEW COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. JOURNAL ARTICLE CITATION: LOU, W.-S., GU, J.-P., HE, X., CHEN, L., SU, H.-B., CHEN, G.-P., WANG, T. (2009). ENDOVASCULAR TREATMENT FOR ILIAC VEIN COMPRESSION SYNDROME: A COMPARISON BETWEEN THE PRESENCE AND ABSENCE OF SECONDARY THROMBOSIS. KOREAN JOURNAL OF RADIOLOGY, 10(2), 135. DOI: 10.3348/KJR.2009.10.2.135.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE FROM KOREAN JOURNAL OF RADIOLOGY TITLED " ENDOVASCULAR TREATMENT FOR ILIAC VEIN COMPRESSION SYNDROME: A COMPARISON BETWEEN THE PRESENCE AND ABSENCE OF SECONDARY THROMBOSIS " THAT AFTER STENT PLACEMENT IN TWO ILIAC VEIN COMPRESSION SYNDROME (IVCS) PATIENTS WITH RECURRENT DVT PRESENT (3 AND 6 MONTHS AFTER DISCHARGE FOLLOW-UP EVALUATION SHOWING THE IN-STENT RESTENOSIS), BLOOD FLOW WAS SUCCESSFULLY RESTORED IN ONE CASE BY PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND NOT IN THE OTHER DUE TO THE INABILITY TO PASS THE CATHETER AND WIRE BEYOND THE OBSTRUCTION. THE STATUS OF THE PATIENTS WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1309166 E-LUMINEXX VASCULAR STENT VASULAR STENT NIO ANGIOMED GMBH & CO. MEDIZINTECHNIK KG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ASPIRIN 75-300MG OD FOR 6-12 MONTHS| LOW MOLECULAR HEPARIN 4100U FOR 3-5 DAYS| UROKINASE DAILY 250,000-1,000,000U| WARFARIN 1.25 - 5 MG OD FOR 1-6 MONTHS