BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMIMICS 3D VASCULAR STENT SYSTEM

    MDR report key: 10676388 · Received October 14, 2020

    Report

    Report Number
    3011632150-2020-00061
    Event Type
    Injury
    Date Received
    October 14, 2020
    Date of Event
    September 1, 2020
    Report Date
    October 14, 2020
    Manufacturer
    VERYAN MEDICAL LTD
    Product Code
    NIP
    UDI-DI
    05391526850060
    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#: 3011632150-2020-00060. 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

    THERE IS NO EVIDENCE TO SUGGEST THE DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT. THIS MDR REPORT IS RELATED TO MDR#: 3011632150-2020-00060. THE PATIENT WAS ENROLLED IN THE BIOMIMICS 3D POST MARKET OBSERVATIONAL STUDY ON (B)(6)2018. THE PATIENT HAD TWO BIOMIMICS 3D VASCULAR STENTS IMPLANTED AT INDEX PROCEDURE ON (B)(6) 2018 TO TREAT A DE NOVO OCCLUSION OF THE SFA PROXIMAL THIRD TO SFA DISTAL THIRD OF THE LEFT LEG. ON THE (B)(6) 2020 A RESTENOSIS OF TREATED VESSEL (TARGET VESSEL) WAS IDENTIFIED AND WAS DESCRIBED AS POSSIBLY RELATED TO THE PROCEDURE AND DEVICE. THIS EVENT OF RESTENOSIS REQUIRED A PERCUTANEOUS INTERVENTION THAT INCLUDED A TARGET LESION REVASCULARISATION (TLR) WHICH INCLUDED BYPASS SURGERY. THE OUTCOME IS DESCRIBED AS RESOLVED AND THE PATIENT HAS RECOVERED. THE DEVICES REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140617 BIOMIMICS 3D VASCULAR STENT SYSTEM BIOMIMICS 3D VASCULAR STENT SYSTEM NIP VERYAN MEDICAL LTD 433882 05391526850060

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R