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

Model Number 142122-07

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

Patient Problems Impaired Healing (2378); Localized Skin Lesion (4542); Restenosis (4576)

Event Date 05/06/2022

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 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 Description

The patient was treated as part of the mimics 3d usa post-market observational study.On the (b)(6) 2021, the patient was implanted with one biomimics 3d (bm3d) stent, a 7.0 x 80 mm stent which was used to treat a denovo lesion of the superficial femoral artery (sfa) middle third to distal third in the right leg.A contralateral approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was post-dilated with pta.The site identified a restenosis of treated segment (target lesion) on (b)(6) 2022.It was reported as not related to the device or procedure but due to a worsening pre-existing condition.It was also reported as target lesion related.A right leg extremity (rle) revascularisation was done on (b)(6) 2022.The right sfa, popliteal (pop) and anterior tibial (at) arteries were treated with orbital laser atherectomy and pta/standard balloon angioplasty.The mid segment of the stent had mild in-stent restenosis (isr).The intervention was reported as a target lesion/vessel revascularisation (tlr/tvr).The outcome was reported as resolved/recovered.The device remains implanted.This event was reviewed by veryan and considered possibly related to the device.

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 worsening of peripheral arterial disease leading to additional surgical intervention, endovascular intervention or amputation are listed in the biomimics 3d instructions for use and are known patient effects 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.Section b.3.Was updated with the date of onset 06-may-22, b.5.Was updated to reflect the stalled wound healing identified by the site, d.3.And g.1.Were updated with veryan's new address, g.6.And h.2.Reflect the type of report (follow-up 01) and its reason, h.6.Was updated to reflect the wound identified that had stalled and h.11.Was updated to reflect the sections of this report that have been updated.

Event Description

The patient was treated as part of the mimics 3d usa post-market observational study.On the (b)(6) 2021, the patient was implanted with one biomimics 3d (bm3d) stent, a 7.0 x 80 mm stent which was used to treat a denovo lesion of the superficial femoral artery (sfa) middle third to distal third in the right leg.A contralateral approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was post-dilated with pta.The site identified a restenosis of treated segment (target lesion) on (b)(6) 2022.It was reported as not related to the device or procedure but due to a worsening pre-existing condition.It was also reported as target lesion-related.The site noticed that wound healing had stalled at the patient's visit on (b)(6) 2022.A right lower extremity (rle) revascularisation was done on (b)(6) 2022.The right sfa, popliteal (pop) and anterior tibial (at) arteries were treated with orbital laser atherectomy and pta/standard balloon angioplasty.The mid segment of the stent had mild in-stent restenosis (isr).The segments treated were the sfa middle third to at proximal third.The intervention was reported as a target lesion/vessel revascularisation (tlr/tvr).The outcome was reported as resolved/recovered.The device remains implanted.This event was reviewed by veryan and considered possibly related to the device.Additional information was provided by the site on 27-feb-24 to reflect that wound healing which had stalled was identified on (b)(6) 2022 and the date of onset was updated from 20-may-22 to 06-may-22.

• 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: 17256629
• MDR Text Key: 318551534
• Report Number: 3011632150-2023-00076
• Device Sequence Number: 1
• Product Code: NIP
• 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: 03/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2022
• Device Model Number: 142122-07
• Device Catalogue Number: 142122-07
• Device Lot Number: 0000058438
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2020
• 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.; CLOPIDOGREL (PLAVIX).
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 259 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White