BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMIMICS 3D VASCULAR STENT SYSTEM

    MDR report key: 10483715 · Received September 2, 2020

    Report

    Report Number
    3011632150-2020-00044
    Event Type
    Injury
    Date Received
    September 2, 2020
    Date of Event
    February 7, 2020
    Report Date
    September 2, 2020
    Manufacturer
    VERYAN MEDICAL LTD
    Product Code
    NIP
    UDI-DI
    05391526850107
    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 EFFECTS OF OCCLUSION/RESTENOSIS ARE 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 · 1

    THERE IS NO EVIDENCE TO SUGGEST THE DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT OF OCCLUSION/RESTENOSIS. THE REPORTED PATIENT EFFECTS OF OCCLUSION/RESTENOSIS ARE 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. THIS SUBJECT WAS ENROLLED IN THE BIOMIMICS 3D POST MARKET OBSERVATIONAL STUDY ON (B)(6) 2017. THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2017 AND INVOLVED TREATMENT OF A DENOVO OCCLUSION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO DISTAL THIRD IN THE RIGHT LEG. ONE BIOMIMICS STENT WAS IMPLANTED. THE EVENT WAS REPORTED TO VERYAN AS AN OCCLUSION ON THE (B)(6) 2020 AND WAS DESCRIBED AS NOT RELATED TO THE DEVICE OR PROCEDURE. THE EVENT WAS NOT REPORTABLE WHEN IT WAS SUBMITTED ORIGINALLY BASED ON THE INFORMATION PROVIDED. FOLLOWING UPDATED INFORMATION RECEIVED BY VERYAN ON 04-AUG-2020 FOLLOWING A QUERY TO THE SITE, THIS HIGHLIGHTED THAT A TARGET LESION REVASCULARISATION (TLR) HAD OCCURRED TO TREAT THE EVENT . THE SEGMENT TREATED INVOLVED THE SFA DISTAL THIRD AND INCLUDED DRUG COATED BALLOON / DRUG ELUTING BALLOON AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY / STANDARD BALLOON ANGIOPLASTY. THE EVENT IS DESCRIBED AS RESOLVED AND THE PATIENT HAS RECOVERED. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945491 BIOMIMICS 3D VASCULAR STENT SYSTEM BIOMIMICS 3D VASCULAR STENT SYSTEM NIP VERYAN MEDICAL LTD 401863 05391526850107

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization