BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMIMICS 3D VASCULAR STENT SYSTEM

    MDR report key: 11921536 · Received June 2, 2021

    Report

    Report Number
    3011632150-2021-00022
    Event Type
    Injury
    Date Received
    June 2, 2021
    Report Date
    June 2, 2021
    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

    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 EFFECT, 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 PATIENT 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

    THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT. THE PATIENT WAS TREATED AS PART OF THE (B)(6) POST-MARKET OBSERVATIONAL STUDY ON (B)(6) 2018. THE PATIENT WAS TREATED WITH A 5.0 X 100MM BIOMIMICS 3D DEVICE ON (B)(6) 2018 TO TREAT A DE-NOVO OCCLUSION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) OSTIAL TO SFA PROXIMAL THIRD OF THE LEFT LEG. ON AN UNKNOWN DATE IN 2019 A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED. IT WAS REPORTED AS "POSSIBLY RELATED" TO THE DEVICE. IT REQUIRED A TARGET LESION REVASCULARISATION (TLR) THAT INVOLVED PERCUTANEOUS INTERVENTION USING DRUG COATED BALLOON/DRUG ELUTING BALLOON TO REVASCULARISE THE SFA PROXIMAL THIRD ARTERIAL SEGMENT. THIS WAS CONDUCTED ON (B)(6) 2019. THE EVENT IS RESOLVED AND THE SUBJECT HAS RECOVERED. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819518 BIOMIMICS 3D VASCULAR STENT SYSTEM BIOMIMICS 3D VASCULAR STENT SYSTEM NIP VERYAN MEDICAL LTD 436118 05391526850060

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R