BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 15102138 · Received July 26, 2022

    Report

    Report Number
    3001845648-2022-00463
    Event Type
    Injury
    Date Received
    July 26, 2022
    Date of Event
    January 20, 2022
    Report Date
    November 22, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: P050017/S002 AND S003. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    ZILVER VENA PRODUCT CODE: QAN; 510 K # P200023. 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. ¿TOWNSEND_2022 HIGHLIGHTED.PDF¿. IT IS NOT KNOWN FROM THE JOURNAL ARTICLE WHAT DEVICE WAS USED IN THE STUDY SO THE INVESTIGATION IS BASED ON A ZVT7 DEVICE AS PER MEDICAL ADVISOR INPUT. 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. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0091) STATES ¿THE ZILVER VENA VENOUS STENT IS INDICATED FOR IMPROVING DIAMETER IN THE ILIOFEMORAL VEINS FOR THE TREATMENT OF SYMPTOMATIC ILIOFEMORAL VENOUS OUTFLOW OBSTRUCTION¿. IT SHOULD ALSO BE NOTED THAT THE IFU LISTS RESTENOSIS, OCCLUSION OR THROMBOSIS OF THE STENTED VEIN AS A KNOWN POTENTIAL ADVERSE EVENT. THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. THERE IS 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 OF OFF LABEL USE CAN BE CONCLUDED BASED ON THE INFORMATION PROVIDED. THE IFU STATES THE ZILVER VENA STENT IS INDICATED FOR USE IN THE ILIOFEMORAL VEINS, HOWEVER FROM THE ARTICLE IT IS KNOWN THAT THE DEVICE WAS USED IN THE DURAL SINUS. IT SHOULD ALSO BE NOTED THAT RESTENOSIS, OCCLUSION OR THROMBOSIS OF THE STENTED VEIN IS A KNOWN POTENTIAL ADVERSE EVENT LISTED IN THE IFU. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE COMPLAINT WAS RAISED FROM LITERATURE PAPER TOWNSEND ET AL ¿MAJOR COMPLICATIONS OF DURAL VENOUS SINUS STENTING FOR IDIOPATHIC INTRACRANIAL HYPERTENSION: CASE SERIES AND MANAGEMENT CONSIDERATIONS¿. ACCORDING TO THE INITIAL REPORTER, THE PATIENT REQUIRED AN ADDITIONAL PROCEDURE AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    TOWNSEND ET AL 2021 ¿ ¿MAJOR COMPLICATIONS OF DURAL VENOUS SINUS STENTING FOR IDIOPATHIC INTRACRANIAL HYPERTENSION: CASE SERIES AND MANAGEMENT CONSIDERATIONS¿. COMPLICATION 3 (DELAYED IN-STENT THROMBOSIS): A PATIENT IN THEIR 30S PRESENTED WITH BLURRED VISION AND PAPILLEDEMA REFRACTORY TO MEDICAL THERAPY. VENOGRAPHY DEMONSTRATED A 15 MMHG GRADIENT ACROSS SEVERE RIGHT-SIDED TS STENOSIS. THE PATIENT WAS PLACED ON DUAL ANTIPLATELET THERAPY OF ASPIRIN 325 MG AND CLOPIDOGREL 75 MG DAILY FOR 7 DAYS PRE-PROCEDURE (CLOPIDOGREL RESPONSE TESTING NOT PERFORMED) AND UNDERWENT RIGHT VSS UNDER GENERAL ANESTHESIA WITH PLACEMENT OF A ZILVER 6 MM × 40 MM STENT (COOK MEDICAL, BLOOMINGTON, IN) ACROSS THE STENOTIC RIGHT TS IN THE STANDARD FASHION. THERE WERE NO IDENTIFIED INTRAOPERATIVE COMPLICATIONS AND THE PATIENT WAS AWOKEN FROM GENERAL ANESTHESIA AND DISCHARGED. THREE WEEKS AFTER THE PROCEDURE THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH 1 WEEK OF PROGRESSIVE HEADACHES WITHOUT NEUROLOGIC DEFICIT. CT VENOGRAPHY DEMONSTRATED OCCLUSION OF THE RIGHT TS STENT. THE PATIENT WAS TAKEN TO THE ANGIOGRAPHY SUITE WHERE THEY UNDERWENT REVASCULARIZATION USING A TRI-AXIAL SYSTEM WITH AN ACE 68 (PENUMBRA, ALAMEDA, CA) FOR ASPIRATION AND THEN A UNIFUSE CATHETER (ANGIODYNAMICS, LATHAM, NY) TO DELIVER TISSUE PLASMINOGEN ACTIVATOR (TPA) INFUSION. THE THROMBUS WAS RIGID, AND THE UNIFUSE CATHETER WAS MANEUVERED WITH SIGNIFICANT DIFFICULTY INTO THE CLOT AND PERI-TORCULAR SSS. WEIGHT-BASED TPA WAS THEN INFUSED THROUGH THIS CATHETER OVER 3 DAYS, IN ADDITION TO SYSTEMIC INTRAVENOUS HEPARIN INFUSION. THE PATIENT UNDERWENT CATHETER DIRECTED VENOGRAPHY POSTOPERATIVE DAYS 1 AND 2 FOR MONITORING OF THE STENT, WHICH REMAINED PATENT. AFTER THE UNIFUSE CATHETER WAS REMOVED ON POSTOPERATIVE DAY 3, SELECTIVE VENOUS MANOMETRY DEMONSTRATED A PERSISTENT GRADIENT OF 6 MMHG. THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY OF ASPIRIN 325 MG AND CLOPIDOGREL 75 MG DAILY. CLOPIDOGREL RESPONSE TESTING WAS NOT PERFORMED. GRADE 4 PAPILLEDEMA DID NOT RESOLVE, SO THE PATIENT UNDERWENT VENTRICULOPERITONEAL SHUNT (VPS) PLACEMENT 1 MONTH AFTER REVASCULARIZATION AFTER HOLDING CLOPIDOGREL FOR 1 WEEK. THE PAPILLEDEMA IMPROVED AFTER VPS PLACEMENT AND THE PATIENT WAS MANAGED ON THE PREVIOUS DUAL ANTIPLATELET THERAPY, WITH EVENTUAL TRANSITION TO ASPIRIN MONOTHERAPY. THE MOST RECENT CT VENOGRAM OBTAINED ON ASPIRIN MONOTHERAPY DEMONSTRATED A PATENT STENT. HYPERCOAGULABILITY WORKUP OBTAINED DURING THE THROMBOSIS ADMISSION REVEALED A SIGNIFICANT LEVEL OF IMMUNOGLOBULIN G (IGG) ANTIBODIES TO ¿-2 GLYCOPROTEIN I RECEPTOR, SIGNIFYING POSSIBLE ANTIPHOSPHOLIPID SYNDROME. THIS FILE WILL CAPTURE OFF LABEL USE OF THE ZILVER STENT IN THE RIGHT TRANSVERSE SINUS AND STENT OCCLUSION REQUIRING REVASCULARISATION. CT VENOGRAPHY DEMONSTRATED OCCLUSION OF THE RIGHT TS STENT. THE PATIENT WAS TAKEN TO THE ANGIOGRAPHY SUITE WHERE THEY UNDERWENT REVASCULARIZATION USING A TRI-AXIAL SYSTEM WITH AN ACE 68 (PENUMBRA, ALAMEDA, CA) FOR ASPIRATION AND THEN A UNIFUSE CATHETER (ANGIODYNAMICS, LATHAM, NY) TO DELIVER TISSUE PLASMINOGEN ACTIVATOR (TPA) INFUSION.

    Description of Event or Problem · 0

    SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS ON THE (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708203 UNKNOWN NIO STENT, ILIAC NIO COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention