BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMIMICS 3D VASCULAR STENT SYSTEM

    MDR report key: 12851920 · Received November 22, 2021

    Report

    Report Number
    3011632150-2021-00044
    Event Type
    Malfunction
    Date Received
    November 22, 2021
    Date of Event
    October 28, 2021
    Report Date
    January 12, 2022
    Manufacturer
    VERYAN MEDICAL LTD
    Product Code
    NIP
    UDI-DI
    05391526850510
    PMA / PMN Number
    P180003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DETAILED REVIEW OF ALL THE LOT HISTORY RECORDS PERTAINING TO THE RELEVANT STENT AND DELIVERY SYSTEM LOTS SHOWED NO ISSUES THAT WERE DEEMED RELATED TO THE COMPLAINT INVESTIGATION. FURTHER INFORMATION ON THE CASE WAS PROVIDED INCLUDING SMARTPHONE IMAGES. THESE WERE NOT THE ORIGINAL PROCEDURAL ANGIOGRAPHIC IMAGE FILES. THE ORIGINAL IMAGES WERE REQUESTED BUT THESE HAVE NOT YET BEEN RECEIVED. THE IMAGES PROVIDED WERE REVIEWED AND CONFIRMED THAT THE DISTAL EDGE OF THE STENT WAS POSITIONED BELOW THE CORTICAL MARGIN OF THE FEMUR WHICH WOULD BE OUTSIDE THE APPROVED INDICATIONS FOR USE. THE IMAGES DID NOT CONFIRM THE PRESENCE OF ANY STENT FRACTURE(S), HOWEVER THERE WAS EVIDENCE OF A DISTORTION OF THE STENT PATTERN BUT THE EXTENT OF THIS COULD NOT BE DETERMINED FROM THE IMAGES. THERE WAS ALSO EVIDENCE OF AN ANEURYSM WHICH WAS LOCATED IN THE PROXIMITY OF THE DISTORTED STENT PATTERN. IN THE ABSENCE OF THE ORIGINAL ANGIOGRAPHIC IMAGES OR OTHER PROCEDURAL INFORMATION, IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE ANEURYSM. IT IS POSSIBLE THAT IF THE ANEURYSM OCCURRED PRIOR TO THE DISTORTION OF THE STENT PATTERN, IT COULD HAVE CREATED ATYPICAL CONDITIONS (E.G. ENLARGED VESSEL DIAMETER) WHICH WOULD HAVE CAUSED AN UNSUPPORTED STENT WHEN SUBJECTED TO PHYSIOLOGICAL LOADING COULD LEAD TO DEFORMATION. THE CAUSE CATEGORIES ASSIGNED ARE UNKNOWN AND USER AS A RESULT OF THE POSITIONING OUTSIDE OF THE STENTS'S APPROVED INDICATION. THE TYPE OF EVENT (SECTION B.1.) HAS BEEN UPDATED TO INCLUDE ADVERSE EVENT AND PRODUCT PROBLEM. THE DESCRIPTION OF THE EVENT (SECTION B.5.) AND THE ADVERSE EVENT CODING (SECTION H.6.) HAVE BEEN UPDATED BASED ON THE UPDATED INFORMATION OBTAINED FOLLOWING COMPLETION OF THE INVESTIGATION. IF FURTHER INFORMATION REGARDING THIS EVENT BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION IS ONGOING. THE DEVICE IS NOT RETURNING FOR EVALUATION. ANGIOGRAPHY IMAGING WILL BE REVIEWED AS PART OF THE INVESTIGATION. IF FURTHER INFORMATION REGARDING THIS EVENT BECOMES AVAILABLE OR ONCE THE INVESTIGATION IS CONCLUDED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2021, A VERYAN SALES REPRESENTATIVE WAS MADE AWARE OF A STENT FRACTURE OF A BIOMIMICS 3D STENT IN THE DISTAL SUPERFICIAL FEMORAL ARTERY TO PROXIMAL POPLITEAL ARTERY (SFA/PPA). THE EVENT OCCURRED ON THE SAME DAY. THE DEVICE FRACTURED RESULTING IN PSEUDOANEURYSM. THE DEVICE REMAINS IMPLANTED AND SMARTPHONE ANGIOGRAPHIC IMAGING IS AVAILABLE. THE PHYSICIAN BELIEVES THAT THE INCIDENT IS RELATED TO THE DEVICE. AS PART OF THE INVESTIGATION OF THIS COMPLAINT, IMAGES PROVIDED WERE REVIEWED BUT NO EVIDENCE OF A STENT FRACTURE COULD BE FOUND. IT WAS OBSERVED THAT THE STENT WAS IMPLANTED IN A REGION WHERE THE DISTAL END OF THE STENT WAS POSITIONED BELOW THE DISTAL CORTICAL MARGIN OF THE FEMUR WHICH IS OUTSIDE THE BIOMIMICS 3D APPROVED INDICATIONS FOR USE. THERE WAS EVIDENCE OF A DISTORTED STENT PATTERN. THE IMAGES WERE NOT THE ORIGINAL ANGIOGRAPHIC IMAGING FILES AND THE EXTENT OF STENT PATTERN DISTORTION WAS NOT POSSIBLE TO DETERMINE. AN ANEURYSM WAS ALSO OBSERVED IN THE PROXIMITY OF THE STENT PATTERN DISTORTION BUT IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE ANEURYSM OR IF IT IS RELATED TO THE DISTORTED STENT PATTERN. IF THE ANEURYSM OCCURRED PRIOR TO THE DISTORTED STENT PATTERN IT COULD HAVE CREATED ATYPICAL CONDITONS (E.G. VESSEL DIAMETER WIDENS) AND THE STENTED REGION BECOMES UNSUPPORTED WHEN SUBJECT TO PHYSIOLOGICAL LOADING.

    Description of Event or Problem · 0

    ON 28 OCT 2021, A VERYAN SALES REPRESENTATIVE WAS MADE AWARE OF A STENT FRACTURE OF A BIOMIMICS 3D STENT IN THE DISTAL SUPERFICIAL FEMORAL ARTERY TO PROXIMAL POPLITEAL ARTERY (SFA/PPA). THE EVENT OCCURRED ON THE SAME DAY. THE DEVICE FRACTURED RESULTING IN PSEUDOANEURYSM. THE DEVICE REMAINS IMPLANTED ANGIOGRAPHIC IMAGING IS AVAILABLE. THE PHYSICIAN BELIEVES THAT THE INCIDENT IS RELATED TO THE DEVICE. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1748457 BIOMIMICS 3D VASCULAR STENT SYSTEM BIOMIMICS 3D VASCULAR STENT SYSTEM NIP VERYAN MEDICAL LTD 144700-12 0000061412 05391526850510

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H