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

Catalog Number 131816-02

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

Patient Problem Restenosis (4576)

Event Date 05/25/2020

Event Type  Injury  

Manufacturer Narrative

There was no reported device malfunction and the device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to 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 occlusion/restenosis 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.

Event Description

There is no evidence to suggest the device caused or contributed to this event.The patient was treated as part of the (b)(6) post-market observational study on (b)(6) 2017.At index procedure ((b)(6) 2017), the patient presented with a restenotic occlusion of the segment involving the proximal popliteal artery of the left leg.One biomimics stent (a 6.0 x 60mm stent) was implanted.On (b)(6) 2020 a restenosis of the treated vessel between the sfa proximal third and proximal popliteal artery was identified.The event was described as "possibly related" to the device and "not related" to the procedure.Percutaneous intervention took place on (b)(6) 2020 and included drug coated balloon / drug eluting balloon.The event is reported as being not target lesion related and the revascularisation was also described as being a non-target lesion revascularisation.Following review of this event with veryan's chief medical officer a query was submitted to the reporting site for a rationale on the relationship to the device, given that the event is indicated to be not target lesion related or a target lesion revascularisation.Veryan have not had a response from the site on this query and therefore veryan are reporting this in order to take the most conservative approach.The outcome of the event is that it has resolved and patient has recovered.The device remains implanted.

Event Description

There is no evidence to suggest the device caused or contributed to this event.The patient was treated as part of the mimics-3d european post-market observational study on (b)(6) 2017.At index procedure ((b)(6) 2017), the patient presented with a restenotic occlusion of the segment involving the proximal popliteal artery of the left leg.One biomimics stent (a 6.0 x 60mm stent) was implanted.On 25-may-2020 a restenosis of the treated vessel between the sfa proximal third and proximal popliteal artery was identified.The event was described as "possibly related" to the device, this was updated to "not related" on 22-march-2021.It was confirmed that the restenosis was distal to the device and related to disease progression.It was "not related" to the procedure.Percutaneous intervention took place on (b)(6) 2020 and included drug coated balloon / drug eluting balloon.The event is reported as being not target lesion related and the revascularisation was also described as being a non-target lesion revascularisation.Following review of this event following receipt in (b)(6) 2020 with (b)(6) chief medical officer, a query was submitted to the reporting site for a rationale on the relationship to the device, which was subsequently answered on (b)(6) 2021 and the relationship to the device was updated to "not related".Based on the updated information provided this event is not reportable and this supplemental is being submitted to update the original mdr submitted on (b)(6) 2020.The outcome of the event is that it has resolved and patient has recovered.The device remains implanted.

Manufacturer Narrative

Based on updated information received on the 22-march-2021, this event of restenosis of treated vessel (target vessel) was reported as "not related" to the device as the restenosis was distal to the implanted biomimics-3d device and target lesion and was due to underlying disease progression.The adverse event description has been updated to reflect this new information.The reported patient effects of restenosis 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.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Type of Device: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL; unit 11 galway technology park; parkmore road; galway city, H91 V E0H; EI H91 VE0H
• MDR Report Key: 11065000
• MDR Text Key: 223389017
• Report Number: 3011632150-2020-00062
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850015
• UDI-Public: (01)05391526850015(17)181130(11)170529(10)403146
• Combination Product (y/n): N
• PMA/PMN Number: P180003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 131816-02
• Device Lot Number: 403146
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLOPIDOGREL (PLAVIX); CLOPIDOGREL (PLAVIX); RIVAROXABAN; CLOPIDOGREL (PLAVIX); CLOPIDOGREL (PLAVIX); RIVAROXABAN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 72