BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMIMICS 3D VASCULAR STENT SYSTEM

    MDR report key: 14210252 · Received April 26, 2022

    Report

    Report Number
    3011632150-2022-00019
    Event Type
    Injury
    Date Received
    April 26, 2022
    Date of Event
    January 11, 2022
    Report Date
    April 26, 2022
    Manufacturer
    VERYAN MEDICAL LTD
    Product Code
    NIP
    UDI-DI
    05391526850510
    PMA / PMN Number
    P180003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 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 EFFECTS OF RESTENOSIS LEADING TO INTERVENTION IS LISTED IN THE BIOMIMICS 3D INSTRUCTIONS FOR USE AND ARE KNOWN PATIENT EFFECTS 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 EVIDENCE TO SUGGEST THAT THE DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT. THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY ON (B)(6) 2021 TO TREAT A DENOVO LESION IN THE SFA PROXIMAL THIRD TO DISTAL THIRD OF THE RIGHT LEG. AN EVENT OF RESTENOSIS WAS ORIGINALLY REPORTED TO VERYAN AS NOT RELATED TO THE DEVICE OR PROCEDURE AND DUE TO WORSENING OF THE PRE-EXISTING CONDITION. THE EVENT WAS IDENTIFIED VIA ULTRASOUND THAT SHOWED A STENOSIS IN THE DISTAL SFA. THE EVENT DID REQUIRE A TARGET LESION REVASCULARISATION THAT INCLUDED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY / STANDARD BALLOON ANGIOPLASTY AND LASER / ATHERECTOMY. THIS WAS CONDUCTED ON (B)(6) 2022. THE OUTCOME OF THE EVENT IS REPORTED AS RESOLVED/RECOVERED. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773859 BIOMIMICS 3D VASCULAR STENT SYSTEM BIOMIMICS 3D VASCULAR STENT SYSTEM NIP VERYAN MEDICAL LTD 144700-12 0000080291 05391526850510

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention| H ASPIRIN| CLOPIDOGREL (PLAVIX)