BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMIMICS 3D VASCULAR STENT SYSTEM

    MDR report key: 11746024 · Received April 29, 2021

    Report

    Report Number
    3011632150-2021-00014
    Event Type
    Injury
    Date Received
    April 29, 2021
    Date of Event
    March 17, 2021
    Report Date
    April 30, 2021
    Manufacturer
    VERYAN MEDICAL LTD
    Product Code
    NIP
    UDI-DI
    05391526850039
    PMA / PMN Number
    P180003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS RELATED TO MDR NUMBER: 3011632150-2021-00015. 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 IS LISTED IN THE BIOMIMICS 3D INSTRUCTIONS FOR USE AND IS A KNOWN AND POTENTIAL ADVERSE EFFECT 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 IS RELATED TO MDR NUMBER: 3011632150-2021-00015. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT. THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D EUROPEAN POST-MARKET OBSERVATIONAL STUDY ON (B)(6) 2018. THE PATIENT WAS IMPLANTED WITH TWO BIOMIMICS-3D DEVICES (5.0 X 80MM AND 6.0 X 60MM) TO TREAT A DE-NOVO OCCLUSION IN THE SFA DISTAL THIRD TO PROXIMAL POPLITEAL ARTERY OF THE RIGHT LEG. ON (B)(6) 2021, A RESTENOSIS OF TREATED SEGMENT WAS IDENTIFIED WHICH REQUIRED PERCUTANEOUS INTERVENTION TO REVASCULARISE THE TARGET LESION. THE EVENT IS REPORTED AS "POSSIBLY RELATED" TO THE STUDY DEVICE AND "POSSIBLY RELATED" TO THE PROCEDURE. NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE SITE. THE OUTCOME IS DESCRIBED AS "RESOLVED/RECOVERED". THE DEVICES REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645447 BIOMIMICS 3D VASCULAR STENT SYSTEM BIOMIMICS 3D VASCULAR STENT SYSTEM NIP VERYAN MEDICAL LTD 388058 05391526850039

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R