BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMIMICS 3D VASCULAR STENT SYSTEM

    MDR report key: 9834298 · Received March 16, 2020

    Report

    Report Number
    3011632150-2020-00021
    Event Type
    Injury
    Date Received
    March 16, 2020
    Date of Event
    February 11, 2020
    Report Date
    March 16, 2020
    Manufacturer
    VERYAN MEDICAL
    Product Code
    NIP
    PMA / PMN Number
    P180003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS RELATED TO MDR NUMBER 3011632150-2020-00022. 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/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

    THIS REPORT IS RELATED TO MDR NUMBER 3011632150-2020-00022. THE PATIENT WAS TREATED AS PART OF THE (B)(6) STUDY ON (B)(6) 2018. AT INDEX PROCEDURE ((B)(6) 2018), THE PATIENT PRESENTED WITH A DENOVO OCCLUSION OF THE SEGMENT INVOLVING THE DISTAL THIRD OF THE SFA AND THE DISTAL POPLITEAL ARTERY IN THE RIGHT LEG. TWO BIOMIMICS STENTS WERE IMPLANTED. ONE 5.0 X150 MM BIOMIMICS 3D DEVICE AND ONE 5.0 X 125 MM BIOMIMICS 3D DEVICE. ON (B)(6) 2020 AN OCCLUSION EVENT WAS IDENTIFIED. THE RELATIONSHIP TO THE DEVICE AND PROCEDURE WERE DESCRIBED AS BEING "NOT RELATED". THE OCCLUSION REQUIRED A TARGET LESION REVASCULARISATION AND WAS TREATED WITH DRUG COATED BALLOON / DRUG ELUTING BALLOON, PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY / STANDARD BALLOON ANGIOPLASTY AND THROMBECTOMY WHICH TOOK PLACE ON (B)(6) 2020. THE EVENT HAS RESOLVED AND THE PATIENT HAS RECOVERED. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301398 BIOMIMICS 3D VASCULAR STENT SYSTEM BIOMIMICS 3D VASCULAR STENT SYSTEM NIP VERYAN MEDICAL 420375

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization