BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMIMICS 3D VASCULAR STENT SYSTEM

    MDR report key: 14877540 · Received June 30, 2022

    Report

    Report Number
    3011632150-2022-00040
    Event Type
    Injury
    Date Received
    June 30, 2022
    Date of Event
    May 9, 2022
    Report Date
    June 30, 2022
    Manufacturer
    VERYAN MEDICAL LTD
    Product Code
    NIP
    UDI-DI
    05391526850510
    PMA / PMN Number
    P180003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW HAS BEEN PERFORMED OF THE MANUFACTURING CERTIFICATE OF CONFORMANCE ASSOCIATED WITH THIS LOT. THERE WERE NO NON-CONFORMANCES OR DEVIATIONS WHICH COULD BE ASSOCIATED WITH 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 EFFECTS OF RESTENOSIS AND CLAUDICATION PAIN REQUIRING ENDOVASCULAR INTERVENTION 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 · 0

    THERE IS NO DEVICE DEFICIENCY OR MALFUNCTION ASSOCIATED WITH THIS EVENT. THE PATIENT WAS ENROLLED IN THE BIOMIMICS 3D US REGISTRY STUDY ON (B)(6) 2021. THE PATIENT WAS IMPLANTED WITH ONE BIOMIMICS 3D VASCULAR STENT TO TREAT A DE NOVO LESION OF THE SFA (SUPERFICIAL FEMORAL ARTERY) MIDDLE THIRD TO DISTAL THIRD IN THE LEFT LEG. ON THE (B)(6) 2022 A RESTENOSIS OF THE TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED. THE PATIENT WAS SEEN IN CLINIC WITH ARTERIAL DUPLEX SHOWING SIGNIFICANT RECURRENT DISEASE BILATERALLY WITH RUTHERFORD 3 CLAUDICATION. SUBJECT UNDERWENT PERIPHERAL INTERVENTION ON (B)(6) 2022 FOR IN STENT RESTENOSIS TO STUDY STENT AND AREA OF 80% STENOSIS TO UPPER LEFT SFA ( STUDY LEG) THAT WAS TREATED WITH A NON STUDY BIOMIMICS STENT; AND RIGHT SFA IN STENT STENOSIS OF 80% WAS NOTED. THE INTERVENTION INCLUDED A TARGET LESION REVASCULARISATION (TLR) THAT INVOLVED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY / STANDARD BALLOON ANGIOPLASTY AND LASER ATHERECTOMY WITH IVUS. THE EVENT IS RESOLVED AND PATIENT IS RECOVERED AND WAS DISCHARGED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014497 BIOMIMICS 3D VASCULAR STENT SYSTEM BIOMIMICS 3D VASCULAR STENT SYSTEM NIP VERYAN MEDICAL LTD 144700-12 0000061412 05391526850510

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention| H ASPIRIN| CLOPIDOGREL (PLAVIX)