BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMIMICS 3D VASCULAR STENT SYSTEM

    MDR report key: 9172358 · Received October 9, 2019

    Report

    Report Number
    3011632150-2019-00093
    Event Type
    Injury
    Date Received
    October 9, 2019
    Report Date
    November 29, 2019
    Manufacturer
    VERYAN MEDCIAL
    Product Code
    NIP
    PMA / PMN Number
    P180003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS RELATED MDR NUMBER 3011632150-2019-00093. COMPLAINT ANALYSIS INVOLVED ANGIOGRAPHY REVIEW OF THE ANGIOGRAPHS TAKEN AT INDEX PROCEDURE ON (B)(6) 2017 AND ALSO ANGIOGRAPHS TAKEN AT THE RE-INTERVENTION ON THE (B)(6) 2018. THE INDEX PROCEDURE SHOWED A TARGET LESION FOCAL STENOSIS IN THE DISTAL SFA. THIS WAS TREATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), AND A BIOMIMICS 3D VASCULAR STENT WAS USED TO TREAT A VESSEL DISSECTION AND FOLLOWING STENT PLACEMENT THERE WAS A RESIDUAL DISSECTION ABOVE THE STENT. THE RE-INTERVENTION ANGIOGRAPHS SHOWED THAT THERE WAS A 90% DIFFUSE RESTENOSIS OF THE PROXIMAL TWO-THIRDS OF THE BIOMIMICS 3D DEVICE. THE RESTENOSIS OCCURS INSIDE THE STENT AND AT THE SITE OF PTA AND RESIDUAL DISSECTION ABOVE THE STENT. A 50% RESTENOSIS IS APPARENT IN THE DISTAL ONE THIRD OF THE DEVICE. THE BLOCKAGE WAS INITIALLY TREATED USING A 6 X 60MM ADMIRAL BALLOON, WHICH WAS IMMEDIATELY FOLLOWED BY PTA WITH A DRUG ELUTING BALLOON (DEB) ADMIRAL BALLOON. THE RESTENOSED STENT WAS SUCCESSFULLY REOPENED. THE STENT APPEARANCE FOLLOWING DEPLOYMENT AND AT FOLLOW-UP HAD A NORMAL STRUT PATTERN. THE PHYSICIAN HAD ORIGINALLY REPORTED AN ABRUPT CESSATION OF BLOODFLOW LOCATED 1CM PROXIMAL TO THE BIOMIMICS 3D STENT ENTRANCE. THERE WAS NO EVIDENCE OF THIS FOLLOWING COMPLAINT ANALYSIS. WHEN A STENT PLACED IN THE FEMOROPOPLITEAL ARTERY BECOMES TOTALLY OCCLUDED, THE PROXIMAL VESSEL WILL ALSO BECOME OCCLUDED TO THE LEVEL OF THE NEXT MOST PROXIMAL COLLATERAL VESSEL. IN VERYAN'S EXPERIENCE TO DATE THE NATURE OF TOTAL OCCLUSIONS OBSERVED FOR THE BIOMIMICS 3D STENT DOES NOT DIFFER FROM THAT OBSERVED WITH COMPETITOR NITINOL STENT DEVICES USED IN THE FEMOROPOPLITEAL ARTERY. THIS COMPLAINT WAS CATEGORISED AS "IN-STENT RESTENOSIS" DUE TO PROGRESSION OF DISEASE DUE TO ATHEROSCLEROSIS. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE INCIDENT IS STILL BEING INVESTIGATED AND ANY FURTHER INFORMATION WHICH IS RELEVANT WILL BE PROVIDED VIA A FOLLOW-UP/ SUPPLEMENTAL REPORT WITHIN 30 DAYS OF VERYAN MEDICAL BECOMING AWARE.

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED TO VERYAN AS A STENT OCCLUSION AND THE REPORTER COMMENTED ON THE PATTERN OF RESTENOSIS COMPARED TO COMPETITOR NITINOL STENTS. A RE-INTERVENTION TOOK PLACE ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965998 BIOMIMICS 3D VASCULAR STENT SYSTEM BIOMIMICS 3D VASCULAR STENT SYSTEM NIP VERYAN MEDCIAL 401861

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R