BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMIMICS 3D VASCULAR STENT SYSTEM

    MDR report key: 10523615 · Received September 11, 2020

    Report

    Report Number
    3011632150-2020-00047
    Event Type
    Injury
    Date Received
    September 11, 2020
    Date of Event
    February 19, 2020
    Report Date
    September 11, 2020
    Manufacturer
    VERYAN MEDICAL LTD
    Product Code
    NIP
    UDI-DI
    05391526850015
    PMA / PMN Number
    P180003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS RELATED TO MDR NUMBER 3011632150-2020-00046. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THE REPORTED PATIENT EFFECTS OF OCCLUSION/RESTENOSIS ARE LISTED IN THE BIOMIMICS 3D INSTRUCTIONS FOR USE AND ARE KNOWN PATIENT EFFECTS OF PERIPHERAL STENTING PROCEDURES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELLING OF THE DEVICE. IF FURTHER INFORMATION REGARDING THIS EVENT BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS REPORT IS RELATED TO MDR NUMBER: 3011632150-2020-00046. THERE IS NO EVIDENCE TO SUGGEST THE DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT. THIS SUBJECT WAS ENROLLED IN THE BIOMIMICS 3D POST MARKET OBSERVATIONAL STUDY ON (B)(6) 2017. THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2017 AND INVOLVED TREATMENT OF A DENOVO OCCLUSION OF THE PROXIMAL POPLITEAL ARTERY IN THE LEFT LEG. TWO BIOMIMICS STENTS WERE IMPLANTED. THE EVENT WAS REPORTED TO VERYAN AS "OTHER EVENT-PROGRESSION OF PERIPHERAL ARTERIAL DISEASE INVOLVING TARGET LEG AND NON TARGET LEG" ON (B)(6) 2020 AND WAS DESCRIBED AS NOT RELATED TO THE DEVICE OR PROCEDURE BUT RELATED TO A WORSENING PRE - EXISTING CONDITION. AN UPDATE ON THE EVENT PROVIDED TO VERYAN ON 13-AUG-2020 HIGHLIGHTED THAT THE TARGET LESION WAS RELATED TO THE EVENT AND A HIGH GRADE STENOSIS IN THE BIOMIMICS 3D STENT IN THE DISTAL SFA/PROXIMAL POPLITEAL ARTERY WAS IDENTIFIED. A PERCUTANEOUS INTERVENTION WAS PLANNED BUT HAD NOT TAKEN PLACE BY THE TIME THE SUBJECT EXITED THE STUDY ON (B)(6) 2020. AS THE EVENT IS RELATED TO A RESTENOSIS OF THE DEVICE ALTHOUGH THE INTERVENTION HAD NOT TAKEN PLACE BY THE SUBJECT'S STUDY EXIT ON (B)(6) 2020 IT IS BEING BE REPORTED CONSERVATIVELY. THE EVENT IS DESCRIBED AS RESOLVED AND THE PATIENT HAS RECOVERED. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986799 BIOMIMICS 3D VASCULAR STENT SYSTEM BIOMIMICS 3D VASCULAR STENT SYSTEM NIP VERYAN MEDICAL LTD 381851 05391526850015

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R ASPIRIN| CLOPIDOGREL (PLAVIX)| CLOPIDOGREL (PLAVIX)| CLOPIDOGREL (PLAVIX)| CLOPIDOGREL (PLAVIX)| CLOPIDOGREL (PLAVIX)| ENOXAPARIN-NATRIUM