BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER VENA VENOUS SELF-EXPANDING STENT

    MDR report key: 14590808 · Received June 3, 2022

    Report

    Report Number
    3001845648-2022-00344
    Event Type
    Injury
    Date Received
    June 3, 2022
    Date of Event
    April 30, 2021
    Report Date
    October 13, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    QAN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: P200023. COMMON NAME - QAN. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: P200023. SECTION D: COMMON NAME - QAN. DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE IS RELATED TO (B)(4) AND IT WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE REF. ATT. 'SALEM 2021 PRELIMINARY REVIEW - DOC 10-MAY-2022.MSG'. LAB EVALUATION ¿ N/A. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL ZILVER VENA DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0047) LISTS RESTENOSIS OR THROMBOSIS OF THE STENTED VEIN AS A KNOWN POTENTIAL ADVERSE EVENT. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE LABEL. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE OF PATIENT PRE-EXISTING CONDITIONS WAS DETERMINED. BASED ON THE INCLUSION CRITERIA IN THE STUDY, IT IS KNOWN THAT THE PATIENT¿S PRE-EXISTING CONDITIONS INCLUDED PTS OR MTS, IPSILATERAL ILIOFEMORAL DVT AND OCCLUSION AT THE COMMON FEMORAL AND ILIAC VEINS WITH DISTAL PATENT COMMON FEMORAL VEIN AND ADEQUATE INFLOW. IT IS POSSIBLE THAT PATIENT'S PRE-EXISTING CONDITIONS CAUSED AND/OR CONTRIBUTED TO THE LACK OF STENT PATENCY. AS PER MEDICAL ADVISOR INPUT ¿USUALLY EARLY LACK OF PATENCY MAY BE DUE TO THROMBOSIS WHILE LATER LOSS OF PATENCY MORE LIKELY DUE TO RESTENOSIS/DISEASE PROGRESSION/LACK OF ANTICOAGULATION.¿ IT SHOULD BE NOTED THAT THE IFU LISTS RESTENOSIS OR THROMBOSIS OF THE STENTED VEIN AS A KNOWN POTENTIAL ADVERSE EVENT. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE COMPLAINT WAS RAISED FROM LITERATURE PAPER SALEM ET AL 'LONG-TERM OUTCOME OF DEDICATED VENOUS STENTS IN MANAGEMENT OF CHRONIC ILIOFEMORAL OBSTRUCTION'. TWELVE-MONTH PRIMARY PATENCY, ASSISTED PRIMARY AND SECONDARY PATENCY WERE 91.4%, 96.6% AND 98.3% RESPECTIVELY. 5 YEAR PRIMARY PATENCY, ASSISTED PRIMARY AND SECONDARY PATENCY WERE 60.3%, 65.5% AND 81% RESPECTIVELY. AS PER MEDICAL ADVISOR INPUT 'INTERVENTION/ADDITIONAL PROCEDURES WERE REQUIRED TO PREVENT PERMEANT IMPAIRMENT/DAMAGE' LACK OF PRIMARY PATENCY AT 5 YEARS I.E. 23 STENTS WAS SUGGESTED BY MEDICAL ADVISOR AS THE CONFIRMED USED QUANTITY THE STUDY CONCLUDED THAT THE TREATMENT OF ILIOFEMORAL VENOUS OCCLUSIVE DISEASE WITH A ZILVER VENA STENT IS AN EXCELLENT CHOICE FOR PATIENTS WITH OCCLUSIVE POST-THROMBOTIC SYNDROME. THE TECHNIQUE HAS GOOD 1-YEAR AND 5-YEAR PATENCY AND IS ASSOCIATED WITH SIGNIFICANT CLINICAL IMPROVEMENT AND FEW COMPLICATIONS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    SALEM ET AL 2021 - LONG-TERM OUTCOME OF DEDICATED VENOUS STENTS IN MANAGEMENT OF CHRONIC ILIOFEMORAL OBSTRUCTION. OBJECTIVE -TO STUDY THE LONG-TERM OUTCOMES IN PATIENTS WITH OCCLUSIVE ILIOFEMORAL CHRONIC VENOUS INSUFFICIENCY (CVI) OF BENIGN ETIOLOGY TREATED BY DEDICATED VENOUS STENTS (ZILVER VENA STENTS; COOK, BLOOMINGTON, IND) PLACED AT A SINGLE CENTER. WE PERFORMED RETROSPECTIVE ANALYSIS OF PROSPECTIVELY COLLECTED DATA FROM 58 PATIENTS WITH SYMPTOMATIC BENIGN LOWER LIMB CVI DURING THE PERIOD FROM JANUARY 2013 TO OCTOBER 2020. PATIENTS UNDERWENT RECANALIZATION USING ZILVER VENA STENTS AT AIN SHAMS UNIVERSITY HOSPITALS. WE EXCLUDED PATIENTS REQUIRING STENTING AFTER INTERVENTION FOR ACUTE DEEP VENOUS THROMBOSIS, CVI DUE TO MALIGNANCY OR VASCULAR MALFORMATIONS, PREVIOUS IPSILATERAL VENOUS INTERVENTIONS, OR CVI DUE TO NONOBSTRUCTIVE PATHOLOGY (REFLUX). PATIENTS WERE CLINICALLY CLASSIFIED AT ENROLLMENT BY THE CLINICAL, ETIOLOGY, ANATOMY, PATHOLOGY CLASS, VENOUS DISABILITY SCORE, AND VILLALTA SCORE. PRIMARY, ASSISTED PRIMARY, AND SECONDARY STENT PATENCY WERE ASSESSED. PATIENTS WERE FOLLOWED CLINICALLY AND BY DUPLEX, AT 1, 3, 6, 12 MONTHS AND ANNUALLY FOR 5 YEARS. THIS COMPLAINT WAS OPENED TO CAPTURE THE LACK OF STENT PATENCY. TWELVE-MONTH PRIMARY, ASSISTED PRIMARY, AND SECONDARY PATENCY WAS 91.4% , 96.6%, AND 98.3%, RESPECTIVELY. (LACK OF PATENCY IN APPROX. 5 PATIENTS, 2 PATIENTS AND 1 PATIENTS, RESPECTIVELY) 5-YEAR PRIMARY, ASSISTED PRIMARY, AND SECONDARY PATENCY WAS 60.3%, 65.5%, AND 81%, RESPECTIVELY. (LACK OF PATENCY IN APPROX. 23 PATIENTS, 20 PATIENTS AND 11 PATIENTS, RESPECTIVELY). REQUIRE INTERVENTION/ADDITIONAL PROCEDURES TO PREVENT PERMANENT IMPAIRMENT/DAMAGE.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1979136 ZILVER VENA VENOUS SELF-EXPANDING STENT Stent, iliac vein QAN COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Required Intervention