BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMIMICS 3D VASCULAR STENT SYSTEM

    MDR report key: 11783894 · Received May 6, 2021

    Report

    Report Number
    3011632150-2021-00016
    Event Type
    Injury
    Date Received
    May 6, 2021
    Date of Event
    March 9, 2021
    Report Date
    May 6, 2021
    Manufacturer
    VERYAN MEDICAL LTD
    Product Code
    NIP
    UDI-DI
    05391526850008
    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 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 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 BIOMIMICS 3D EUROPEAN POST-MARKET OBSERVATIONAL STUDY ON (B)(6) 2018. THE PATIENT WAS TREATED WITH A 5.0 X 60MM 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 RIGHT LEG. ON (B)(6) 2021 A RESTENOSIS OF TREATED VESSEL (TARGET VESSEL) WAS IDENTIFIED. IT WAS REPORTED AS "POSSIBLY RELATED" TO THE DEVICE. IT REQUIRED PERCUTANEOUS INTERVENTION (DRUG COATED BALLOON/DRUG ELUTING BALLOON AND THROMBECTOMY) TO REVASCULARISE THE SFA OSTIAL TO DISTAL POPLITEAL ARTERY WHICH INCLUDED THE SEGMENT TREATED AT INDEX. THIS WAS CONDUCTED ON (B)(6) 2021. THE EVENT IS RESOLVED AND THE SUBJECT HAS RECOVERED. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679875 BIOMIMICS 3D VASCULAR STENT SYSTEM BIOMIMICS 3D VASCULAR STENT SYSTEM NIP VERYAN MEDICAL LTD 407479 05391526850008

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R ASPIRIN| CLOPIDOGREL (PLAVIX| CLOPIDOGREL (PLAVIX)| CLOPIDOGREL (PLAVIX)