BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-LUMINEXX VASCULAR STENT

    MDR report key: 7807801 · Received August 22, 2018

    Report

    Report Number
    9681442-2018-00142
    Event Type
    Injury
    Date Received
    August 22, 2018
    Date of Event
    October 31, 2013
    Report Date
    November 2, 2018
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT IDENTIFIED FOR THIS EVENT HAS NOT BEEN CLEARED IN THE US, BUT IS SIMILAR TO THE E-LUMINEXX VASCULAR STENT PRODUCTS THAT ARE CLEARED IN THE US. THE 510 K NUMBER AND PRO CODE FOR THE E-LUMINEXX STENT PRODUCTS ARE IDENTIFIED. MANUFACTURING REVIEW: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A MANUFACTURING REVIEW COULD NOT BE PERFORMED. JOURNAL ARTICLE REVIEW: THE PURPOSE OF THE PRESENT STUDY WAS TO PROSPECTIVELY EVALUATE THE FEASIBILITY, SAFETY, AND EFFECTIVENESS OF SINGLE-SESSION ENDOVASCULAR TREATMENT WITH MANUAL ASPIRATION THROMBECTOMY AS THE FIRST-LINE THROMBUS REMOVAL METHOD FOR THE TREATMENT OF ILIAC VEIN COMPRESSION SYNDROME WITH SECONDARY ACUTE ISOLATED ILIAC COMMON FEMORAL DVT. ALL OF THE ENDOVASCULAR PROCEDURES, INCLUDING MAT, BALLOON ANGIOPLASTY, AND STENT PLACEMENT, WERE PERFORMED IN THE SAME SETTING. THE STENOTIC OR OCCLUSIVE ILIAC VEIN WAS DILATED USING A BALLOON CATHETER AND THEN A SELF-EXPANDABLE NITINOL STENT WAS PLACED. A FINAL VENOGRAPHY WAS PERFORMED TO CONFIRM THAT ANTEGRADE IN-LINE FLOW FROM THE POPLITEAL VEIN TO THE IVC WAS RESTORED, AND THE STENOSIS OR OCCLUSION OF THE ILIAC VEIN WAS ELIMINATED. RECANALIZATION OF THE LEFT ILIAC VEIN WAS SUCCESSFUL IN ALL PATIENTS AND A TOTAL OF 26 STENTS, 10-14 MM IN DIAMETER AND 60-100 MM IN LENGTH, WERE PLACED. RECURRENT THROMBOSIS IN THE STENT WAS DETECTED IN ONE PATIENT 11 MONTHS AFTER THE PROCEDURES. AFTER CATHETER-DIRECTED THROMBOLYSIS, SUCCESSFUL RESTORATION OF ANTEGRADE IN-LINE FLOW WITHIN THE STENT WAS OBTAINED. ZHU, Q. H., ZHOU, C. Y., CHEN, Y., WANG, J., MO, H. Y., LUO , M. H., . . . YU, X. F. (2013). PERCUTANEOUS MANUAL ASPIRATION THROMBECTOMY FOLLOWED BY STENTING FOR ILIAC VEIN COMPRESSION SYNDROME WITH SECONDARY ACUTE ISOLATED ILIOFEMORAL DEEP VEIN THROMBOSIS: A PROSPECTIVE STUDY OF SINGLE-SESSION ENDOVASCULAR PROTOCOL. EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY, 47 (1), 68-74. DX.DOI.ORG/10.1016/J.EJVS.2013.09.030 INVESTIGATION SUMMARY: THE PHYSICAL SAMPLE WAS NOT AVAILABLE. THE JOURNAL ARTICLE CONTAINED IMAGES WHICH DEMONSTRATED PATIENT CONDITION BEFORE, DURING, AND AFTER TREATMENT. IT WAS NOT KNOWN WHETHER THE IMAGES WERE RELATED TO THE SUBJECT WHO SUFFERED STENT THROMBOSIS. THE STENTING PROCEDURE WAS JUDGED AS SUCCESSFUL FOR ALL PATIENTS; A DEFICIENCY OF THE STENT COULD NOT BE IDENTIFIED ON THE IMAGES. AN INDICATION FOR A DEVICE RELATION OF THE THROMBOSIS COULD NOT BE DETERMINED. THEREFORE, THE INVESTIGATION OF THIS ISSUE IS CLOSED WITH INCONCLUSIVE RESULT. IN THIS CASE IT WAS REPORTED THAT FOR ALL PATIENTS THE PROCEDURE WAS SUCCESSFUL. BASED ON THE INFORMATION AVAILABLE A DEFINITE ROOT CAUSE FOR THE EVENT REPORTED COULD NOT BE IDENTIFIED. LABELING REVIEW: IN REVIEWING THE RELEVANT LABELING FOR THIS PRODUCT, THE POTENTIAL ISSUE WAS FOUND ADDRESSED AS THE INSTRUCTIONS FOR USE (IFU) STATE THAT 'STENT THROMBOSIS / OCCLUSION' IS A POTENTIAL ADVERSE EVENT THAT MAY OCCUR. THE REPORTED APPLICATION REPRESENTS AN OFF LABEL USE OF THE DEVICE. THE PRODUCT IS INTENDED FOR USE IN THE ILIAC AND FEMORAL ARTERIES.

    Description of Event or Problem · 0

    IT WAS REPORTED IN AN ARTICLE IN EUROPEAN SOCIETY FOR VASCULAR SOCIETY TITLED 'PERCUTANEOUS MANUAL ASPIRATION THROMBECTOMY FOLLOWED BY STENTING FOR ILIAC VEIN COMPRESSION SYNDROME WITH SECONDARY ACUTE ISOLATED ILIOFEMORAL DEEP VEIN THROMBOSIS: A PROSPECTIVE STUDY OF SINGLE-SESSION ENDOVASCULAR PROTOCOL', THAT RECURRENT THROMBOSIS IN THE STENT WAS DETECTED IN ONE PATIENT. AFTER CATHETER-DIRECTED THROMBOLYSIS (CDT), SUCCESSFUL RESTORATION OF ANTEGRADE IN-LINE FLOW WITHIN THE STENT WAS OBTAINED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFIED FOR THIS EVENT HAS NOT BEEN CLEARED IN THE US, BUT IS SIMILAR TO THE E-LUMINEXX VASCULAR STENT PRODUCTS THAT ARE CLEARED IN THE US. THE 510 K NUMBER AND PRO CODE FOR THE E-LUMINEXX STENT PRODUCTS ARE IDENTIFIED. MEDICAL IMAGES WERE PROVIDED AND ARE BEING REVIEWED. NO HOSPITAL/MEDICAL RECORDS HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WILL NOT BE PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. JOURNAL ARTICLE REVIEW: THE PURPOSE OF THE PRESENT STUDY WAS TO PROSPECTIVELY EVALUATE THE FEASIBILITY, SAFETY, AND EFFECTIVENESS OF SINGLE-SESSION ENDOVASCULAR TREATMENT WITH MANUAL ASPIRATION THROMBECTOMY AS THE FIRST-LINE THROMBUS REMOVAL METHOD FOR THE TREATMENT OF ILIAC VEIN COMPRESSION SYNDROME WITH SECONDARY ACUTE ISOLATED ILIAC COMMON FEMORAL DVT. ALL OF THE ENDOVASCULAR PROCEDURES, INCLUDING MAT, BALLOON ANGIOPLASTY, AND STENT PLACEMENT, WERE PERFORMED IN THE SAME SETTING. THE STENOTIC OR OCCLUSIVE ILIAC VEIN WAS DILATED USING A BALLOON CATHETER AND THEN A SELF-EXPANDABLE NITINOL STENT WAS PLACED. A FINAL VENOGRAPHY WAS PERFORMED TO CONFIRM THAT ANTEGRADE IN-LINE FLOW FROM THE POPLITEAL VEIN TO THE IVC WAS RESTORED, AND THE STENOSIS OR OCCLUSION OF THE ILIAC VEIN WAS ELIMINATED. RECANALIZATION OF THE LEFT ILIAC VEIN WAS SUCCESSFUL IN ALL PATIENTS AND A TOTAL OF 26 STENTS, 10-14 MM IN DIAMETER AND 60-100 MM IN LENGTH, WERE PLACED. RECURRENT THROMBOSIS IN THE STENT WAS DETECTED IN ONE PATIENT 11 MONTHS AFTER THE PROCEDURES. AFTER CATHETER-DIRECTED THROMBOLYSIS, SUCCESSFUL RESTORATION OF ANTEGRADE IN-LINE FLOW WITHIN THE STENT WAS OBTAINED. JOURNAL ARTICLE CITATION: ZHU, Q.H., ZHOU, C.Y., CHEN , Y., WANG , J., MO, H.Y., LUO , M.H.,... YU, X.F. (2013). PERCUTANEOUS MANUAL ASPIRATION THROMBECTOMY FOLLOWED BY STENTING FOR ILIAC VEIN COMPRESSION SYNDROME WITH SECONDARY ACUTE ISOLATED ILIOFEMORAL DEEP VEIN THROMBOSIS: A PROSPECTIVE STUDY OF SINGLE-SESSION ENDOVASCULAR PROTOCOL. EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY, 47 (1), 68-74. DX.DOI.ORG/10.1016/J.EJVS.2013.09.030 THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE ARTICLE "PERCUTANEOUS MANUAL ASPIRATION THROMBECTOMY FOLLOWED BY STENTING FOR ILIAC VEIN COMPRESSION SYNDROME WITH SECONDARY ACUTE ISOLATED ILIOFEMORAL DEEP VEIN THROMBOSIS: A PROSPECTIVE STUDY OF SINGLE-SESSION ENDOVASCULAR PROTOCOL" IN THE EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY 2014 THAT RECURRENT THROMBOSIS IN THE STENT WAS DETECTED IN ONE PATIENT. AFTER CATHETER-DIRECTED THROMBOLYSIS (CDT), SUCCESSFUL RESTORATION OF ANTEGRADE IN-LINE FLOW WITHIN THE STENT WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647244 E-LUMINEXX VASCULAR STENT VASCULAR STENT NIO ANGIOMED GMBH & CO. MEDIZINTECHNIK KG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention