BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMIMICS 3D VASCULAR STENT SYSTEM

    MDR report key: 11996161 · Received June 14, 2021

    Report

    Report Number
    3011632150-2021-00027
    Event Type
    Injury
    Date Received
    June 14, 2021
    Date of Event
    March 9, 2021
    Report Date
    July 13, 2021
    Manufacturer
    VERYAN MEDICAL LTD
    Product Code
    NIP
    UDI-DI
    05391526850268
    PMA / PMN Number
    P180003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IDENTIFIER PART OF THE UDI HAS BEEN CORRECTED TO (B)(4).

    Additional Manufacturer Narrative · 1

    THIS IS RELATED TO MDR NUMBER 3011632150-2021-00028. 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 THROMBOSIS/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 MDR REPORT IS RELATED TO MBER 3011632150-2021-00028. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT. THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY ON 09 FEB 2021. THE SUBJECT WAS IMPLANTED WITH TWO BIOMIMICS-3D STENTS (A 7.0 X 150MM AND A 7.0 X 125MM) ON (B)(6) 2021 TO TREAT A DENOVO OCCLUSION (100% STENOSIS) WITH A TARGET LESION LENGTH OF 200MM OF THE SFA PROXIMAL THIRD TO SFA MIDDLE THIRD OF THE RIGHT LEG. A RETROGRADE APPROACH WAS USED, AND PRE-DILATATION AND POST-DILATATION OF THE TARGET LESION WERE CONDUCTED WITH STANDARD BALLOON ANGIOPLASTY/PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. ATHERECTOMY WAS ALSO PERFORMED PRE STENT PLACEMENT. AN OCCLUSION, EARLY (7 - 30 DAYS TREATED VESSEL) WAS REPORTED TO VERYAN ON (B)(6) 2021. THE EVENT WAS REPORTED TO VERYAN AS "POSSIBLY RELATED" TO THE DEVICE AND "DEFINITELY RELATED" TO THE PROCEDURE ON (B)(6) 2021 BY THE CLINICAL SITE. IT WAS REPORTED AS REQUIRING PERCUTANEOUS INTERVENTION, THROMBOLYTICS ARTERIAL DOPPLER AND IMAGING. THE INTERVENTION WHICH WAS REPORTED AS A TARGET LESION REVASCULARISATION (TLR) TOOK PLACE ON (B)(6) 2021. THERE WAS HEAVY CALCIFICATION AT THE DISTAL END OF THE PREVIOUSLY PLACED BIOMIMICS 3D STENT. THIS LEAD TO IN-STENT OCCLUSION AS WELL AS SUBOPTIMAL EXPANSION OF BIOMIMICS STENT. LASER ATHERECTOMY AND ANGIOPLASTY WERE PERFORMED IN-STENT TO CLEAR OCCLUSION, BUT SIGNIFICANT CALCIFICATION REMAINED, SO LITHOTRIPSY BALLOON WAS USED. THERE WAS STILL SIGNIFICANT CALCIFICATION JUST BELOW PRIOR STENT, SO AGAIN ANGIOPLASTY WAS PERFORMED AND A NON BIOMIMICS 3D STENT WAS PLACED, WHICH OVERLAPPED DISTAL END OF PRIOR STENT. THERE WAS A SMALL AMOUNT OF THROMBUS NOTED IN STENT WHICH WILL BE TREATED WITH ELIQUIS AND ONGOING ASPIRIN AND PLAVIX. THE SUBJECT WAS DISCHARGED THE NEXT DAY WITHOUT ADDITIONAL COMPLICATIONS. THE EVENT IS RESOLVED, AND PATIENT HAS RECOVERED. THE DEVICES REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886260 BIOMIMICS 3D VASCULAR STENT SYSTEM BIOMIMICS 3D VASCULAR STENT SYSTEM NIP VERYAN MEDICAL LTD 0000049879 05391526850268

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R ASPIRIN| CLOPIDOGREL (PLAVIX)| ELIQUIS| HEPARIN IV| HEPARIN IV