BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMIMICS 3D VASCULAR STENT SYSTEM

    MDR report key: 9178550 · Received October 11, 2019

    Report

    Report Number
    3011632150-2019-00098
    Event Type
    Injury
    Date Received
    October 11, 2019
    Report Date
    October 11, 2019
    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 IS THE SAME CASE AS MDR NUMBER 3011632150-2019-00099. 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 CLAUDICATION AND 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

    THIS IS THE SAME CASE AS MDR NUMBER 3011632150-2019-00099. THE PATIENT WAS TREATED AS PART OF THE (B)(6) STUDY ON 2018. AT INDEX PROCEDURE ((B)(6) 2018), THE PATIENT PRESENTED WITH A RESTENOTIC OCCLUSION LOCATED IN THE MIDDLE TO DISTAL THIRD OF THE SUPERFICIAL FEMORAL ARTERY (SFA) OF THE RIGHT LEG. A 6.0 X 150 MM BIOMIMICS 3D STENT AND BIOMIMICS 3D A 6.0 X 125MM STENT WAS IMPLANTED. ON AN UNKNOWN DATE IN 2019 AN OCCLUSION OF THE TARGET LIMB AND TARGET LESION/ STENT WAS REPORTED. ON (B)(6) 2019 THE PATIENT HAD A RE-INTERVENTION PROCEDURE CONSISTING OF A FEMORO-POPLITEAL BYPASS. THE OUTCOME OF THE EVENT IS THAT IT HAS RESOLVED AND PATIENT HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972863 BIOMIMICS 3D VASCULAR STENT SYSTEM BIOMIMICS 3D VASCULAR STENT SYSTEM NIP VERYAN MEDICAL 423827

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R