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

Model Number	142122-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	12/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 is a known patient effect 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
The patient was treated as part of the mimics 3d usa post-market observational study on (b)(6) 2021.The subject was implanted with one biomimics-3d stent (a 6.0 x 100mm ) to treat a restenotic lesion of the sfa middle third artery in the left leg.A retrograde 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 (b)(6) 2022, 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".On review of the event by veryan on (b)(6) 2022, it was determined to be possibly related to the device as it led to a target lesion revascularisation (tlr).The intervention included percutaneous transluminal angioplasty / standard balloon angioplasty, drug coated/drug eluting balloon, shockwave and laser atherectomy which took place on (b)(6) 2022.The device remains implanted.
Additional Manufacturer Narrative
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 is a known patient effect of peripheral stenting procedures.There is no indication of a product quality issue with respect to the design, manufacture or labelling of the device.Section b.5.Has been updated following the updated information provided from the site.If further information regarding this event becomes available, a follow-up report will be submitted.
Event or Problem Description
The patient was treated as part of the mimics 3d usa post-market observational study on 21-apr-2021.The subject was implanted with one biomimics-3d stent (a 6.0 x 100mm ) to treat a restenotic lesion of the sfa middle third artery in the left leg.A retrograde 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 (b)(6) 2022, 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 originally but this was later updated by the site to "possibly related" to the device on (b)(6) 2022.It was also reported as target lesion related.The patient outcome is reported as "resolved/recovered".On review of the event by veryan on (b)(6) 2022, it was determined to be possibly related to the device as it led to a target lesion revascularisation (tlr).The intervention included percutaneous transluminal angioplasty / standard balloon angioplasty, drug coated/drug eluting balloon, shockwave and laser atherectomy which took place on the (b)(6) 2022.The device remains implanted.

• 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 city, H91 V-E0H ; EI H91 VE0H
• MDR Report Key: 14884807
• Report Number: 3011632150-2022-00042
• Device Sequence Number: 6307156
• Product Code: NIP
• UDI-Device Identifier: 05391526850459
• UDI-Public: (01)05391526850459(17)220715(11)201214(10)0000063198
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Report Date (Section B): 09/22/2022

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: 07/15/2022
• Device Model Number: 142122-10
• Device Catalogue Number: 142122-10
• Device Lot Number: 0000063198
• 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: 06/02/2022
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2020
• 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.; CLOPIDOGREL (PLAVIX).; HEPARIN IV.; HEPARIN IV.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White