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

Catalog Number	142122-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Restenosis (4576)
Date of Event	06/09/2022
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 leading to intervention and claudication/pain 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 or Problem Description
The patient was treated as part of the mimics 3d usa post-market observational study.On (b)(6) 2021, the patient was implanted with one biomimics 3d (bm3d) stent in the left leg, a 6.0 x 100 mm stent which was used to treat a denovo lesion in the superficial femoral artery (sfa) middle third.A retrograde approach was used and the lesion was prepared using pre-dilation with a percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was post-dilated with pta.On (b)(6) 2022, at the patient's 12-month duplex ultrasound (dus), it showed severely elevated velocities of the left proximal and mid sfa.The site identified a restenosis of treated vessel (target vessel) event when the patient was seen in the clinic on (b)(6) 2022 where rutherford class iii symptoms were noted.It was reported as not related to the device and not related to the procedure but was due to a worsening pre-existing condition.It was not target lesion related.A diagnostic angiography on (b)(6) 2022 found a severely calcified lesion just above the target lesion in the proximal to mid sfa with stenosis of greater than 70%.A left leg intervention was performed on (b)(6) 2022 and involved laser/atherectomy, pta/standard balloon angioplasty and drug coated/eluting balloon (deb/dcb) on the sfa proximal third to sfa middle third.An incomplete expansion as well as dissection were noted so a 7.0 x 60 mm non-bm3d bare metal stent was placed.The stenosis was reduced to less than 10%.The intervention was reported as a target vessel revascularisation (tvr).The outcome was reported as resolved/recovered.The device remains implanted.The event was reviewed by veryan on 03-jan-24 and considered possibly related to the device.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Common Device Name: 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: 18612714
• Report Number: 3011632150-2024-00002
• Device Sequence Number: 14055092
• Product Code: NIP
• UDI-Device Identifier: 05391526850459
• UDI-Public: (01)05391526850459(17)220715(11)201214(10)0000063198
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/31/2024

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: 07/15/2022
• Device Catalogue Number: 142122-10
• Device Lot Number: 0000063198
• 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: 01/03/2024
• Initial Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2020
• 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: ASPIRIN; CILOSTAZOL (PLETAL); CLOPIDOGREL (PLAVIX)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White