BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMIMICS 3D VASCULAR STENT SYSTEM

    MDR report key: 10631300 · Received October 5, 2020

    Report

    Report Number
    3011632150-2020-00057
    Event Type
    Injury
    Date Received
    October 5, 2020
    Date of Event
    March 18, 2020
    Report Date
    October 5, 2020
    Manufacturer
    VERYAN MEDICAL LTD
    Product Code
    NIP
    UDI-DI
    05391526850329
    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# :3011632150-2020-00055 AND 3011632150-2020-00056. 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 EFFECT OF RESTENOSIS/OCCLUSION IS LISTED IN THE BIOMIMICS 3D INSTRUCTIONS FOR USE. 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 MDR IS RELATED TO MDR#: 3011632150-2020-00055 AND 3011632150-2020-00056. THERE IS NO EVIDENCE TO SUGGEST THE DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT. THE PATIENT WAS ENROLLED IN THE BIOMIMICS 3D POST MARKET OBSERVATIONAL STUDY ON (B)(6) 2017. THE PATIENT HAD THREE BIOMIMICS 3D VASCULAR STENTS IMPLANTED AT INDEX PROCEDURE ON (B)(6) 2017 TO TREAT A DE NOVO OCCLUSION OF THE SFA MIDDLE THIRD TO PROXIMAL POPLITEAL OF THE LEFT LEG. ON (B)(6) 2020, A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED. THIS WAS AN IN STENT OCCLUSION IDENTIFIED AT 36-MONTH FOLLOW-UP. IT REQUIRED A PERCUTANEOUS INTERVENTION, BUT THIS HAD NOT TAKEN PLACE AT THE TIME THE PATIENT EXITED THE STUDY ON (B)(6) 2020. IT IS BEING REPORTED IN ORDER TO TAKE THE MOST CONSERVATIVE APPROACH. THE OUTCOME IS DESCRIBED AS CONTINUING AND THE DEVICES REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1092088 BIOMIMICS 3D VASCULAR STENT SYSTEM BIOMIMICS 3D VASCULAR STENT SYSTEM NIP VERYAN MEDICAL LTD 390273 05391526850329

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention