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

Model Number 142122-15

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

Patient Problems Discomfort (2330); Restenosis (4576)

Event Date 02/02/2023

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 effects of restenosis leading to intervention and leg pain/claudication are listed in the biomimics 3d instructions for use and are 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 the (b)(6) 2022, the patient was implanted with one biomimics 3d (bm3d) stent (a 7.0 x 125mm stent) to treat a denovo lesion of the superficial femoral artery (sfa) proximal third in the right leg.A contralateral approach was used and the lesion was pre-dilated with percutaneous transluminal angioplasty (pta) and atherectomy.The treated segment was post-dilated with pta.The site reported that on (b)(6) 2023, a restenosis of treated segment (target lesion) was identified.The patient was seen in the clinical office on (b)(6) 2023 with some right leg discomfort.Duplex ultrasound (dus) showed high-grade velocities in proximal and mid sfa with significant dropping flows distal to this and decreasing ankle brachial indexes (abis).A right leg angiogram was conducted on (b)(6) 2023.The event was successfully treated with medication and percutaneous intervention, which involved a pta / standard balloon angioplasty of the sfa proximal third and anterior tibial artery on(b)(6) 2023 with good results.It was reported as a target lesion revascularisation (tlr) / target vessel revascularisation (tvr).The event of restenosis was reported as possibly related to the device and not related to the procedure.It was reported as target lesion related.The patient outcome was reported as resolved/recovered and the device remains implanted.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Type of Device: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL LTD; unit 11 galway technology park; parkmore road; galway, H91 V E0H; EI H91 VE0H
• Manufacturer Contact: alan mcdonagh ; unit 11 galway technology park; parkmore road; galway, H91VE-0H ; EI H91VE0H
• MDR Report Key: 16479206
• MDR Text Key: 310619464
• Report Number: 3011632150-2023-00028
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850497
• UDI-Public: (01)05391526850497(17)221007(11)210308(10)0000076765
• 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: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2022
• Device Model Number: 142122-15
• Device Catalogue Number: 142122-15
• Device Lot Number: 0000076765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2021
• 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.; CLOPIDOGREL (PLAVIX).
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 91 KG