MAUDE Adverse Event Report: VERYAN MEDICAL LTD BIOMIMICS 3D VASCULAR STENT SYSTEM

Model Number	142122-07
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	04/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is related to 3011632150-2022-00027.There was no reported device malfunction and the device was not returned for analysis.A review has been performed of the manufacturing certificate of conformance associated with this lot.There were no non-conformances or deviations which could be associated with 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 effect of restenosis is 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.
Event or Problem Description
This mdr is related to 3011632150-2022-00027.The patient was treated as part of the mimics 3d usa post-market observational study on (b)(6) 2021.The subject was implanted with two biomimics-3d stents (a 7.0 x 60mm and a 7.0 x 80mm) to treat a denovo lesion of the sfa middle third to distal third artery in the left leg.A contralateral approach was used and pre-dilatation and post-dilatation of the target lesion was conducted with percutaneous transluminal angioplasty.Atherectomy was also performed pre stent placement.On the 30-april, an event of restenosis of treated segment (target lesion) was reported from the site.It was reported as "not related" to the device or procedure but to worsening pre-existing condition.It was also reported as target lesion related.The patient outcome is reported as "resolved/recovered." the device remains implanted.On review of the event at safety monitoring review (smr) by veryan, it was determined to be possibly related to the device.
Additional Manufacturer Narrative
Date of report corrected from 04 june 2022 to 01 june 2022.
Additional Manufacturer Narrative
This mdr is related to 3011632150-2022-00027.This event of restenosis was subsequently removed from the study database by the clinical site and this supplemental report is updating the information provided on the initial report.
Event or Problem Description
This mdr is related to 3011632150-2022-00027.The patient was treated as part of the mimics 3d usa post-market observational study on (b)(6) 2021.The subject was implanted with two biomimics-3d stents (bm3d) (a 7.0 x 60mm and a 7.0 x 80mm - the subject of this report ) to treat a denovo lesion of the superficial femoral artery (sfa) middle third to distal third artery in the left leg.A contralateral approach was used and pre-dilatation and post-dilatation of the target lesion was conducted with percutaneous transluminal angioplasty (pta).Atherectomy was also performed pre stent placement.On the 30-april-22, an event of restenosis of treated segment (target lesion) was reported from the site.This event of restenosis was subsequently removed from the study database by the clinical site.It was reviewed by veryan on 28-nov-22 and as a result of the removal of the event by the site, this mdr supplemental is updating the information provided on the initial report.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Common Device Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL LTD; unit 11 galway technology park; parkmore road; galway city, H91 V E0H; EI H91 VE0H
• Manufacturer Contact: alan mcdonagh ; unit 11 galway technology park; parkmore road,; galway, h91 ve0h, ; EI
• MDR Report Key: 14561798
• Report Number: 3011632150-2022-00028
• Device Sequence Number: 12237357
• Product Code: NIP
• UDI-Device Identifier: 05391526850435
• UDI-Public: (01)05391526850435(17)220430(11)200929(10)0000052896
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P180003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 142122-07
• Device Catalogue Number: 142122-07
• Device Lot Number: 0000052896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2022
• Supplement Date Received by Manufacturer: 05/05/2022; 05/05/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 06/01/2022; 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN.; ELIQUIS.; WARFARIN.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American