BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMIMICS 3D VASCULAR STENT SYSTEM

    MDR report key: 14517899 · Received May 26, 2022

    Report

    Report Number
    3011632150-2022-00024
    Event Type
    Injury
    Date Received
    May 26, 2022
    Date of Event
    April 6, 2022
    Report Date
    April 11, 2024
    Manufacturer
    VERYAN MEDICAL LTD
    Product Code
    NIP
    UDI-DI
    05391526850459
    PMA / PMN Number
    P180003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS RELATED TO MDR NUMBER 3011632150-2022-00023. 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 RESTENOSIS LEADING TO ADDITIONAL SURGICAL INTERVENTION AND CLAUDICATION 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS RELATED TO MDR NUMBER 3011632150-2022-00023. 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 RESTENOSIS LEADING TO ADDITIONAL SURGICAL INTERVENTION AND CLAUDICATION 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. SECTION B.5. WAS UPDATED WITH THE ADDITIONAL INFORMATION RECEIVED ON 13-MAR-24.

    Description of Event or Problem · 0

    THIS MDR IS RELATED TO MDR NUMBER 3011632150-2022-00023. 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 20 DEC 2021 TO TREAT A RESTENOTIC LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD TO SFA DISTAL THIRD OF THE RIGHT LEG WITH TWO BIOMIMICS 3D VASCULAR STENTS. AN EVENT OF RESTENOSIS WAS ORIGINALLY REPORTED TO VERYAN ON 08 APR 2022 AS "POSSIBLY RELATED" TO THE DEVICE BUT WAS REPORTED AS NOT SERIOUS AS THERE WAS NO INTERVENTION AT THE TIME. AN UPDATE ON THE 27-APR-22 REPORTED THAT SUBJECT ATTENDED THE PHYSICIAN'S OFFICE AND WAS ADMITTED DUE TO RECURRENT CLAUDICATION IN THE RIGHT LEG. ULTRASOUND SHOWED A GREATER THAN 75% STENOSIS OF THE RIGHT PROXIMAL SFA. ANGIOGRAM WAS CONDUCTED ON (B)(6) 2022 WHICH REVEALED AN APPROXIMATE 82% STENOSIS OF THE SFA PROXIMAL WITH SOFT PLAQUE IN THE STENTED PORTION. THE INTERVENTION REQUIRED A TARGET LESION REVASCULARISATION (TLR) THAT INCLUDED DRUG COATED BALLOON / DRUG ELUTING BALLOON AND LASER / ATHERECTOMY. THE PATIENT OUTCOME IS REPORTED AS RESOLVED AND THE PATIENT HAS RECOVERED. THE DEVICE(S) REMAIN IMPLANTED.

    Description of Event or Problem · 0

    THIS REPORT IS RELATED TO MDR NUMBER 3011632150-2022-00023. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT. THE PATIENT WAS TREATED AS PART OF THE (B)(6) STUDY ON (B)(6) 2021 TO TREAT A RESTENOTIC LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD TO SFA DISTAL THIRD OF THE RIGHT LEG WITH TWO BIOMIMICS 3D VASCULAR STENTS. A 6.0 X 150 MM BM3D AND 6.0 X 100 MM BM3D STENT (THE SUBJECT OF THIS REPORT) WERE USED. AN EVENT OF RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED ON (B)(6) 2022 AND ORIGINALLY REPORTED TO VERYAN ON 08-APR-22 AS "POSSIBLY RELATED" TO THE DEVICE BUT WAS REPORTED AS NOT SERIOUS AS THERE WAS NO INTERVENTION AT THE TIME. IT WAS NOT PROCEDURE-RELATED. AN UPDATE ON 27-APR-22 REPORTED THAT SUBJECT ATTENDED THE PHYSICIAN'S OFFICE AND WAS ADMITTED DUE TO RECURRENT CLAUDICATION IN THE RIGHT LEG. ULTRASOUND SHOWED A GREATER THAN 75% STENOSIS OF THE RIGHT PROXIMAL SFA. AN ANGIOGRAM WAS CONDUCTED ON 25-APR-22 WHICH REVEALED AN APPROXIMATE 82% STENOSIS OF THE SFA PROXIMAL WITH SOFT PLAQUE IN THE STENTED PORTION. THE INTERVENTION REQUIRED A TARGET LESION REVASCULARISATION (TLR) THAT INCLUDED DRUG COATED BALLOON / DRUG ELUTING BALLOON AND LASER / ATHERECTOMY. THE PATIENT OUTCOME WAS REPORTED AS RESOLVED/RECOVERED. THE DEVICE(S) REMAIN IMPLANTED. ADDITIONAL INFORMATION RECEIVED ON 13-MAR-24 UPDATED THE EVENT FROM A RESTENOSIS OF TREATED VESSEL (TARGET VESSEL) TO RESTENOSIS OF TREATED SEGMENT (TARGET LESION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2605526 BIOMIMICS 3D VASCULAR STENT SYSTEM BIOMIMICS 3D VASCULAR STENT SYSTEM NIP VERYAN MEDICAL LTD 142122-10 0000088892 05391526850459

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention| H ASPIRIN| ASPIRIN| CLOPIDOGREL (PLAVIX)| HEPARIN| XARELTO