BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-LUMINEXX VASCULAR STENT

    MDR report key: 3835932 · Received May 13, 2014

    Report

    Report Number
    9681442-2014-00077
    Event Type
    Injury
    Date Received
    May 13, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 16, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THIS PRODUCT IS NOT SOLD IN THE US THIS EVENT IS BEING REPORTED UNDER REGULATION 21 CFR PART 803 AS IT INVOLVES A SIMILAR DEVICE TO A PMA APPROVED DEVICE SOLD IN THE US UNDER #P080007. 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 WAS RETURNED. IMAGES WERE PROVIDED. THE EVALUATION OF THE IMAGE CONFIRMED THAT TWO STENTS OUT OF THREE WERE FRACTURE. THE STENTS WERE PLACED IN OVERLAPPING TECHNIQUE IN THE RIGHT SFA. THE VESSEL TREATED WITH THE OVERLAPPING STENTS WAS FOUND TO BE SIGNIFICANTLY STENOSED. POTENTIAL FACTOR THAT COULD HAVE LED OR CONTRIBUTED TO THE REPORTED EVENT HAVE BEEN EVALUATED. PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS HAVE BEEN REVIEWED. AN INADVERTENT MOVEMENT OF THE HAND OR INCORRECT HOLDINGS OF THE DELIVERY SYSTEM DURING STENT RELEASE MAY LEAD TO AN IRREGULAR STENT PLACEMENT AND SUBSEQUENT STENT FRACTURE. AN INSUFFICIENT PRE OR POST-DILATION AS WELL AS HIGHLY CALCIFIED OR TORTUOUS VESSELS ALSO MAY BE CONTRIBUTING FACTORS. IN THE CASE, THREE STENTS OF DIFFERENT DIAMETERS WERE PLACED IN OVERLAP. THIS CONTRADICTS THE IFU AND IS CONSIDERED A CONTRIBUTING FACTOR TO THE REPORTED EVENT. HOWEVER, ON THE BASIS OF THE INFORMATION AVAILABLE, A DEFINITE ROOT CAUSE FOR THE VENT REPORTED COULD NOT BE DETERMINED. THE IFU INDICATES THAT STENT FRACTURE AND STENT THROMBOSIS/OCCLUSION ARE POTENTIAL ADVERSE EVENTS THAT MAY OCCUR. FURTHERMORE THE IFU STATES: "IF PLACING TWO OVERLAPPING STENTS, BOTH STENTS MUST HAVE IDENTICAL DIAMETERS. STENTS SHOULD OVERLAP BY AT LEAST 5 MM TO INCLUDE THE FLARED ENDS. DO NOT OVERLAP MORE THAN TWO STENTS".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VASCULAR STENT WAS FOUND TO BE FRACTURED APPROXIMATELY 11 MONTHS POST PLACEMENT IN THE RIGHT SFA. THREE STENTS OF THE SAME TYPE AND BRAND (6 X 120 MM, 6 X 100 MM, 7 X 120 MM) STENT WERE PLACED SUCCESSFULLY IN OVERLAPPING TECHNIQUE IN (B)(6) 2013 WITH NO REMAINING STENOSIS. IN (B)(6) 2014, THE PATIENT PRESENTED WITH PAIN. ANGIOGRAPHY CONFIRMED STENT FRACTURES OF THE 6 X 120 MM AND 7 X 120 MM STENT *THIS RECORD ADDRESSES THE REPORTED ISSUE WITH THE 7 X 120 MM STENT). REPORTEDLY, AN ACUTE THROMBUS WAS CAUSED BY THE FRACTURE. AFTER THROMBOLYTIC THERAPY, THE REMAINING STENOSIS WAS TREATED BY THE PLACEMENT OF AN ADDITIONAL STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285235 E-LUMINEXX VASCULAR STENT VASCULAR STENT NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANWI1100

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention