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

Catalog Number 144700-19

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Restenosis (4576)

Event Date 03/02/2022

Event Type  Injury  

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 leading to intervention 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 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 (bm3d) stent (a 7.0 x 150mm stent) to treat a restenotic lesion of the sfa middle third to sfa distal third artery in the right leg.A contralateral approach was used and the lesion was prepared using pre-dilatation with percutaneous transluminal angioplasty (pta) and laser atherectomy.The treated segment was post-dilated with pta.On (b)(6) 2022, an event of restenosis of treated segment (target lesion) was identified by the site.It was reported as "not related" to the device and "not related" to the procedure but worsening pre-existing condition.It was target lesion-related.The right sfa stent was treated with plain old balloon angioplasty (poba) for in-stent restenosis (isr).The right ostial sfa stenosis was treated with laser atherectomy and poba.The intervention was performed on (b)(6) 2022 and the segment treated was the sfa ostial to proximal popliteal.The patient outcome was reported as "resolved/recovered".It was reported as a target lesion revascularisation (tlr) and target vessel revascularisation (tvr).The device remains implanted.This was reviewed by veryan on 05-mar-24 and considered possibly related to the bm3d device.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Type of Device: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL LTD; block 5; parkmore east business park; galway, H91 V 0TX; EI H91 V0TX
• Manufacturer Contact: alan mcdonagh ; block 5; parkmore east business park; galway, H91 V-0TX ; EI H91 V0TX
• MDR Report Key: 19032790
• MDR Text Key: 339249277
• Report Number: 3011632150-2024-00014
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850527
• UDI-Public: (01)05391526850527(17)220611(11)201110(10)0000056112
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 144700-19
• Device Lot Number: 0000056112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ASPIRIN.; CILOSTAZOL (PLETAL).; CLOPIDOGREL (PLAVIX).
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Hispanic