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

Model Number	142122-14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Restenosis (4576)
Date of Event	02/25/2022
Type of Reportable Event	Serious Injury
Additional 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/claudication is 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 or Problem Description
There is no evidence to suggest that the device caused or contributed to this event.The patient was treated as part of the mimics 3d usa post-market observational study on (b)(6) 2021.The subject was implanted with one biomimics-3d stent (a 6.0 x 125mm) to treat a denovo occlusion of the sfa middle third to distal third in the left leg a contralateral approach was used and pre-dilatation of the target lesion was conducted with percutaneous transluminal angioplasty.Atherectomy was also performed pre stent placement.On the (b)(6), an event of restenosis of treated vessel (target vessel) was reported from the site.It was reported as "not related" to the device or procedure but was target lesion related.Percutaneous intervention was conducted.The details of the intervention have not yet been provided.The comments on the events are as follows: "subject presented for an ultrasound of (b)(6) 2022.He complained of bilateral claudication with the left worse than the right.Ultrasound showed a moderate stenosis in the left sfa.The physician has recommended an angiogram after speaking with the aprn, who saw the subject on (b)(6) 2022.Angiogram was performed and intervention was done".The outcome is reported as "resolved/recovered".The device remains implanted.On review of the event by veryan, it was determined to be possibly related to the device.
Event or Problem Description
There is no evidence to suggest that the device caused or contributed to this event.The patient was treated as part of the mimics 3d usa post-market observational study on (b)(6) 2021.The subject was implanted with one biomimics 3d (bm3d) stent (a 6.0 x 125mm) to treat a denovo lesion in the proximal popliteal segment in the left leg.A contralateral approach was used and the lesion was prepared using pre-dilatation with percutaneous transluminal angioplasty (pta) and atherectomy.On the (b)(6) 2022, an event of restenosis of treated vessel (target vessel) was identified by the site.It was reported as "not related" to the device or procedure but was related to a worsening pre-existing condition.On (b)(6) 2022, the patient presented for an ultrasound and complained of bilateral claudication with the left worse than the right.The ultrasound showed a moderate stenosis of the left superficial femoral artery (sfa).An angiogram and percutaneous intervention were conducted and on (b)(6) 2022, the patient underwent pta/standard balloon angioplasty and laser/atherectomy of the sfa middle third.The event was reported as a target vessel revascularization (tvr) and was not target lesion related.The outcome was reported as "resolved/recovered".The device remains implanted.Following the updated information provided by the site, this event has no relationship with the bm3d device.
Additional 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, this event does not have a relationship with the device and therefore does not meet the criteria of a mdr reportable event.Sections b.5., d.10., g.1., g.3., g.6., h.2., h.6., and h.10.Have been updated.Additional information received on 13-may-22 included the date and details of the intervention performed for the event.Additional information received on 03-jul-23 included updated bm3d treated segment details from "sfa middle third to distal third" to "proximal popliteal", the event was assessed as not related to the target lesion, vessel segments treated during the intervention were updated and it was reported that the intervention did not result in a target lesion revascularisation.If any additional information becomes available it will be provided in a mdr supplemental report.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Common Device Name: 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 (Section G): VERYAN MEDICAL LTD; unit 11 galway technology park; parkmore road; galway city, H91 V E0H; EI H91 VE0H
• Manufacturer Contact: alan mcdonagh ; unit 11 galway technology park; parkmore road; galway, H91 V-E0H ; EI H91 VE0H
• MDR Report Key: 14375230
• Report Number: 3011632150-2022-00021
• Device Sequence Number: 5783057
• Product Code: NIP
• UDI-Device Identifier: 05391526850480
• UDI-Public: (01)05391526850480(17)220329(11)200828(10)0000050212
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P180003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/29/2022
• Device Model Number: 142122-14
• Device Catalogue Number: 142122-14
• Device Lot Number: 0000050212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CLOPIDOGREL (PLAVIX); CLOPIDOGREL (PLAVIX); HEPARIN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White