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

Catalog Number 142122-01

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

Patient Problems Ischemia (1942); Pain (1994); Restenosis (4576)

Event Date 12/14/2023

Event Type  Injury  

Manufacturer Narrative

This is related to mdr report 3011632150-2023-00151.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 ischemia/pain are listed in the biomimics 3d instructions for use and are 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

This is related to mdr report 3011632150-2023-00151.The patient was treated as part of the mimics 3d usa post-market observational study.On (b)(6) 2021, the patient was implanted with two biomimics 3d (bm3d) stents in the right leg, a 5.0 x 150 mm stent which was used to treat a restenotic lesion in the superficial femoral artery (sfa) proximal third to sfa middle third and a 5.0 x 60 mm stent (the subject of this report) which was used to treat a denovo lesion in the sfa middle third to sfa distal third.An antegrade approach was used and the lesion was prepared using pre-dilation with a percutaneous transluminal angioplasty (pta) balloon.The treated segment was post-dilated with pta.The site identified a restenosis of treated segment (target lesion) event on (b)(6) 2023.It was reported as possibly related to the device and not related to the procedure.It was target lesion related.The patient came into the office on (b)(6) 2023 for her 24-month study visit complaining of ischemic rest pain in her right leg (target leg).An ultrasound showed an occlusion in the distal part of her stent.She had an angiogram on her right leg on (b)(6) 2023 which confirmed an occlusion in the distal third of the stent (distal sfa and proximal popliteal).This was treated on (b)(6) 2023 with drug coated balloon / drug eluting balloon (dcb/deb), plain old balloon angioplasty (poba) / pta / standard balloon angioplasty and laser/atherectomy.Further imaging showed some evidence of stenoses at the upper portion of the stent and a small segment of the proximal sfa which was treated with angioplasty.The intervention was reported as a target lesion/vessel revascularisation (tlr/tvr) that involved the sfa proximal third to proximal popliteal artery.The outcome was reported as resolved/recovered.A completion arteriogram showed full resolution of the stenoses with brisk flow and no evidence of complications.The devices remain implanted.

• 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: 18533217
• MDR Text Key: 333088135
• Report Number: 3011632150-2023-00152
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850381
• UDI-Public: (01)05391526850381(17)220813(11)210112(10)0000066597
• 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: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2022
• Device Catalogue Number: 142122-01
• Device Lot Number: 0000066597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2021
• 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: APIXABAN
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 44 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White