BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMIMICS 3D VASCULAR STENT SYSTEM

    MDR report key: 11746007 · Received April 29, 2021

    Report

    Report Number
    3011632150-2021-00013
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    April 6, 2021
    Report Date
    June 11, 2021
    Manufacturer
    VERYAN MEDICAL LTD
    Product Code
    NIP
    UDI-DI
    05391526850510
    PMA / PMN Number
    P180003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY REVIEW WAS COMPLETED. THERE WERE NO ISSUES IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE LOT MET THE RELEVANT IN-PROCESS MONITORING ACCEPTANCE CRITERIA. FURTHER INFORMATION ON THE CASE WAS PROVIDED BY THE RELEVANT VERYAN SALES REPRESENTATIVES. THE TREATMENT PLAN OF THE FEMOROPOPLITEAL ARTERY INCLUDED PLACEMENT OF A SUPERA STENT IN THE POPLITEAL REGION AND A BIOMIMICS 3D STENT FOR THE REMAINING DISEASED SEGMENT. THE VASCULATURE WAS SEVERELY TORTUOUS AND CALCIFIED, WITH A NOTABLY TIGHT ABDOMINAL AORTIC BIFURCATION ANGLE AND TRACKING WAS DIFFICULT, WITH SIGNIFICANT RESISTANCE NOTED BUT DEPLOYMENT OF THE SUPERA STENT WAS SUCCESSFUL. THERE WAS SIGNIFICANT RESISTANCE REPORTED IN TRACKING THE BIOMIMICS 3D DEVICE TO ITS INTENDED SITE. RESISTANCE WAS REPORTED ON INITIATING DEPLOYMENT, MORE FORCE WAS APPLIED AND AFTER 2-3CM OF THE STENT HAD DEPLOYED, THE DELIVERY SYSTEM BROKE AND WAS NO LONGER OPERATIONAL. THE PHYSICIAN MOVED THROUGH THE DEPLOYMENT STEPS AT PACE, DEPLOYING THE STENT RELATIVELY QUICKLY, AND UPON NOTING RESISTANCE ON COMMENCEMENT OF DEPLOYMENT, CONTINUED TO APPLY MORE FORCE. THE DELIVERY SYSTEM WAS REMOVED, AND THE REVEALED STENT HAD FRACTURED AND A PIECE OF THE STENT REMAINED IN THE VESSEL. A SUPERA STENT WAS IMPLANTED OVER THE REMAINING PIECE OF THE BIOMIMICS 3D STENT. A REVIEW OF ANGIOGRAPHIC IMAGES REVEALED THE ACUTE AORTIC BIFURCATION ANGLE AND THE TORTUOSITY OF THE ILIAC ARTERIES. VERYAN'S CMO ALSO STATED "ACUTE AORTIC BIFURCATION AND TORTUOUS ILIACS ARE WELL SHOWN". HE ALSO ADDED THAT TORTUOSITY OF VESSELS INCREASES WITH AGE AND GIVEN THE SUBJECT WAS 96 YEARS OLD, THE CHALLENGING PATIENT ANATOMY WAS EVIDENT. THE REMAINING PART OF THE BIOMIMICS 3D STENT THAT REMAINED IN THE VESSEL INCLUDED THE END CROWN AND THREE RADIOPAQUE MARKERS, WHICH WERE FULLY EXPANDED ALONG WITH THE OVERLAPPED SUPERA STENTS. INVESTIGATION OF THE RETURNED DEVICE REVEALED THE OUTER BRAID TO BIFURCATION HUB BOND HAD SEPARATED, THE INNER SHAFT OF THE DEVICE HAD A SEVERE BEND WITH A NOTEWORTHY KINK. THE DELIVERY SYSTEM HAD A STROKE LENGTH OF 62MM REMAINING INDICATING THAT THERE WAS SIGNIFICANT OUTER BRAID RETRACTION PRIOR TO THE REPORTED DEVICE MALFUNCTION. ELONGATION OF THE OUTER BRAID WAS ALSO NOTED. CROWNS WERE PROTRUDING FROM THE DISTAL END OF THE DEVICE BUT NO RADIOPAQUE MARKERS WERE EVIDENT, INDICATIVE OF THE PART OF THE STENT THAT REMAINED IN THE VESSEL. THE OUTER BRAID TO BIFURCATION HUB ASSEMBLY WAS CONFIRMED TO HAVE BEEN MANUFACTURED AS INTENDED AS THERE WAS EVIDENCE OF SANDING MARKS AT THE PROXIMAL END OF THE OUTER BRAID AND PRESENCE OF ADHESIVE. AN ATTEMPT WAS MADE TO DEPLOY THE STENT BUT THIS WAS ABANDONED AS THE PROCESS FURTHER DISORIENTATED THE PROTRUDING STENT CROWNS. THE LIKELY ROOT CAUSE OF THE COMPLAINT WAS THE ANATOMICAL CONDITION OF THE PATIENT. THE INCREASED RESISTANCE ON THE DEVICE IS HIGHLY LIKELY TO BE RELATED TO THE CHALLENGING ANATOMICAL CONDITIONS, WHICH WOULD HAVE LED TO INCREASED FRICTION PLACED ON THE DEVICE. THE CONTINUED DEPLOYMENT AND INCREASED FORCE APPLIED BY THE USER LED TO SEPARATION OF THE OUTER BRAID TO BIFURCATION HUB BOND, AS WELL AS SEVERE BENDING IN THE DEVICE. THIS INCREASED FORCE IS LIKELY TO HAVE LED TO PARTIAL DEPLOYMENT AND STENT FRACTURE SEPARATING THE EXPOSED 2-3CM OF STENT CROWNS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CHALLENGING PROCEDURE THAT INVOLVED SEVERELY CALCIFIED AND TORTUOUS ANATOMY COMBINED WITH HAVING TO CROSS A TIGHT BIFURCATION ANGLE, THE BIOMIMICS 3D DEPLOYMENT MECHANISM MALFUNCTIONED. THE PROCEDURE INVOLVED PLACING TWO STENTS: A NON BIOMIMICS STENT AT THE POPLITEAL SEGMENT AND A 6 X 150MM BIOMIMICS 3D STENT FROM THE ADDUCTOR HIATUS TO THE PROFUNDA FEMORAL BIFURCATION TO TREAT A DISEASED SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. MULTIPLE GUIDEWIRES WERE USED TO TRACK THROUGH THE TORTUOUS ANATOMY AND THE PHYSICIAN MANAGED TO GAIN ACCESS WITH A 0.014" GUIDEWIRE. LASER ATHERECTOMY WAS USED PRIOR TO PLACING BOTH STENTS. SIGNIFICANT RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE NON BIOMIMICS 3D STENT THROUGH THE TORTUOUS VESSEL ANATOMY TO THE POPLITEAL REGION. THIS STENT WAS SUCCESSFULLY DEPLOYED. A 0.035" GUIDEWIRE WAS USED TO ADVANCE THE BIOMIMICS 3D STENT THROUGH THE TORTUOUS AND CALCIFIED VESSEL AND AGAIN SIGNIFICANT RESISTANCE WAS REPORTED. UPON DEPLOYMENT INITIATION, THE PHYSICIAN IMMEDIATELY NOTICED RESISTANCE. HOWEVER, IN RESPONSE TO THIS, MORE FORCE WAS REPORTEDLY APPLIED BY THE PHYSICIAN TO RETRACT THE OUTER BRAID. AT LEAST 2-3CM OF STENT DEPLOYED BEFORE THE DELIVERY SYSTEM MALFUNCTIONED. THE PHYSICIAN REMOVED THE DELIVERY SYSTEM WHICH FRACTURED THE 2-3CM PORTION OF STENT THAT HAD BEEN DEPLOYED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. AS SOON AS FURTHER INFORMATION REGARDING THIS EVENT BECOMES AVAILABLE A FOLLOW-UP SUPPLEMENTAL REPORT WILL BE PROVIDED WITHIN 30 DAYS OF AWARENESS OF THIS INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CHALLENGING PROCEDURE THAT INVOLVED SEVERELY CALCIFIED AND TORTUOUS ANATOMY COMBINED WITH HAVING TO CROSS A TIGHT BIFURCATION ANGLE, THE BIOMIMICS 3D DEPLOYMENT MECHANISM MALFUNCTIONED. THE PROCEDURE INVOLVED PLACING TWO STENTS: A NON BIOMIMICS STENT AT THE POPLITEAL SEGMENT AND A 6 X 150MM BIOMIMICS 3D STENT FROM THE ADDUCTOR HIATUS TO THE PROFUNDA FEMORAL BIFURCATION TO TREAT A DISEASED SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. MULTIPLE GUIDEWIRES WERE USED TO TRACK THROUGH THE TORTUOUS ANATOMY AND THE PHYSICIAN MANAGED TO GAIN ACCESS WITH A 0.014" GUIDEWIRE. LASER ATHERECTOMY WAS USED PRIOR TO PLACING BOTH STENTS. SIGNIFICANT RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE NON BIOMIMICS 3D STENT THROUGH THE TORTUOUS VESSEL ANATOMY TO THE POPLITEAL REGION. THIS STENT WAS SUCCESSFULLY DEPLOYED. A 0.035" GUIDEWIRE WAS USED TO ADVANCE THE BIOMIMICS 3D STENT THROUGH THE TORTUOUS AND CALCIFIED VESSEL AND AGAIN SIGNIFICANT RESISTANCE WAS REPORTED. UPON DEPLOYMENT INITIATION, THE PHYSICIAN IMMEDIATELY NOTICED RESISTANCE. HOWEVER, IN RESPONSE TO THIS, MORE FORCE WAS REPORTEDLY APPLIED BY THE PHYSICIAN TO RETRACT THE OUTER BRAID. AT LEAST 2-3CM OF STENT DEPLOYED BEFORE THE DELIVERY SYSTEM MALFUNCTIONED. THE PHYSICIAN REMOVED THE DELIVERY SYSTEM WHICH FRACTURED THE 2-3CM PORTION OF STENT THAT HAD BEEN DEPLOYED. THE DEVICE HAS BEEN RETURNED AND WILL BE FURTHER ANALYSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644582 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 96 YR Other