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

Model Number 142122-10

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

Patient Problems Ischemia (1942); Restenosis (4576); Swelling/ Edema (4577)

Event Date 08/03/2022

Event Type  Injury  

Manufacturer Narrative

This is related to mdr report number 3011632150-2022-00077.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 ischemia and restenosis leading to intervention is 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

This is related to mdr report number 3011632150-2022-00077.The patient was treated as part of the mimics 3d usa post-market observational study on (b)(6) 2022 the subject was implanted with two biomimics 3d (bm3d) stents ( 6.0 x 100mm stent (this report) and a 6.0 x 125mm stent) to treat a denovo lesion of the sfa proximal third to proximal popliteal artery in the left leg.A retrograde approach was used and pre- and post-dilatation was conducted with percutaneous transluminal angioplasty (pta).On the (b)(6) 2022, an event of restenosis of treated segment (target lesion) was identified by the site and reported by the site.The patient reported left leg swelling and when assessed at the clinic the site identified new onset left leg paresthesia.Arterial duplex ultrasound (dus) revealed: 50-75% stenosis in common iliac artery (cia) ; 50-75% stenosis in distal femoral artery (dfa) ; 50-75% stenosis in middle sfa stent; <50% stenosis in distal popliteal artery; no flow visualized in anterior tibial artery (ata).It was reported as "not related" to the device and "not related" to the procedure but due to worsening pre-existing condition.It was also reported as target lesion related.The patient underwent a percutaneous intervention on (b)(6) 2022 and it involved a target lesion revascularisation with percutaneous transluminal angioplasty (pta) and laser atherectomy.The devices remain implanted.The patient outcome is reported as "resolved/recovered".It was reviewed on 08-aug-22 by veryan and considered possibly device related.

Event Description

This is related to mdr report number 3011632150-2022-00077_01.The patient was treated as part of the mimics 3d usa post-market observational study on (b)(6) 2022.The subject was implanted with two biomimics 3d (bm3d) stents (a 6.0 x 100mm stent (this report) and a 6.0 x 125mm stent) to treat a denovo lesion of the superficial femoral artery (sfa) proximal third to proximal popliteal artery in the left leg.The 6.0 x 100mm device was placed in the sfa proximal third to sfa distal third segment and the 6.0 x 125mm stent was placed in the sfa distal third to proximal popliteal segment.A retrograde approach was used and pre- and post-dilatation was conducted with percutaneous transluminal angioplasty (pta).On the (b)(6) 2022, an event of restenosis of treated segment (target lesion) was identified by the site and reported by the site.The patient reported left leg swelling and when assessed at the clinic, the site identified new onset left leg extremity (lle) paresthesia.Arterial duplex ultrasound (dus) revealed: 50-75% stenosis in the common iliac artery (cia); 50-75% stenosis in distal femoral artery (dfa); 50-75% stenosis in middle sfa stent; less than 50% stenosis in distal popliteal artery; no flow visualized in anterior tibial artery (ata).It was reported as "possibly related" to the device and "not related" to the procedure.It was also reported as target lesion related.The patient underwent a percutaneous intervention on (b)(6) 2022 and it involved a target lesion revascularisation with percutaneous transluminal angioplasty (pta) and laser atherectomy on the sfa middle third.The devices remain implanted.The patient outcome is reported as "resolved/recovered".

Manufacturer Narrative

Site b5 has been updated to include the site reported device relationship as updated.Section b7 has been updated with details on the intervention on (b)(6) 2021, d4 has been updated to include the expiration date of the device, section d.10.Has been updated to include aspirin only and section e1 has also been updated to add the sites contact number and additional address details.

• 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 city, H91 V E0H; EI H91 VE0H
• Manufacturer Contact: unit 11 galway technology park; parkmore road; galway city, H91 V-E0H
• MDR Report Key: 15355427
• MDR Text Key: 299287013
• Report Number: 3011632150-2022-00076
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850459
• UDI-Public: (01)05391526850459(17)230702(11)211201(10)0000123388
• 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,Followup
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2023
• Device Model Number: 142122-10
• Device Catalogue Number: 142122-10
• Device Lot Number: 0000123388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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; ASPIRIN; ASPIRIN; CLOPIDOGREL (PLAVIX); HEPARIN; HEPARIN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White