BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMIMICS 3D VASCULAR STENT SYSTEM

    MDR report key: 11601846 · Received April 1, 2021

    Report

    Report Number
    3011632150-2021-00011
    Event Type
    Injury
    Date Received
    April 1, 2021
    Date of Event
    November 13, 2020
    Report Date
    April 1, 2021
    Manufacturer
    VERYAN MEDICAL LTD
    Product Code
    NIP
    UDI-DI
    05391526850312
    PMA / PMN Number
    P180003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 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. THE PATIENT WAS TREATED AS PART OF THE MIMICS-3D EUROPEAN POST-MARKET OBSERVATIONAL STUDY ON (B)(6) 2018. AT INDEX PROCEDURE ( (B)(6) 2018), THE PATIENT PRESENTED WITH A DENOVO OCCLUSION OF THE SEGMENT INVOLVING THE SFA (SUPERFICIAL FEMORAL ARTERY) MIDDLE THIRD TO SFA DISTAL THIRD OF THE RIGHT LEG. ONE BIOMIMICS STENT (A 5.0 X 150MM STENT) WAS IMPLANTED.ON (B)(6) 2020 AN OCCLUSION WAS IDENTIFIED. THE EVENT WAS DESCRIBED AS "DEFINITELY RELATED" TO THE DEVICE AND PROCEDURE. THE EVENT IS ALSO REPORTED AS BEING LINKED TO THE TARGET LESION. PERCUTANEOUS INTERVENTION TOOK PLACE ON (B)(6) 2020 AND INCLUDED DRUG COATED BALLOON / DRUG ELUTING BALLOON AND THROMBOLYSIS. THE EVENT IS REPORTED AS A TARGET LESION REVASCULARISATION (TLR). THE OUTCOME OF THE EVENT IS THAT IT HAS RESOLVED AND PATIENT HAS RECOVERED. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499631 BIOMIMICS 3D VASCULAR STENT SYSTEM BIOMIMICS 3D VASCULAR STENT SYSTEM NIP VERYAN MEDICAL LTD 349133 05391526850312

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R