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

Model Number	142122-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	07/15/2022
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 effect of restenosis leading to intervention 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 or Problem 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 6.0 x 100mm biomimics 3d (bm3d) stent to treat a denovo lesion of the superficial femoral artery (sfa) ostial to sfa proximal third in the left leg.A contralateral approach was used and the lesion was prepared using atherectomy and pre-dilated with percutaneous transluminal angioplasty (pta).The treated segment was post-dilated with pta.The site reported that on (b)(6) 2022, a restenosis of treated vessel (target vessel) was identified.It was reported as not related to the device and not related to the procedure but due to a worsening of the pre-existing condition and intercurrent intervention.It was reported as target lesion related.The event occurred in the target limb and involved an in-stent target lesion restenosis.The left sfa middle third to the proximal popliteal segment was treated with a new bm3d bare metal stent placement, pta/standard balloon angioplasty and laser atherectomy on (b)(6) 2022.The event also involved a non-target lesion in the target vessel and a non-target vessel intervention.It was reported as a target lesion revascularisation (tlr) and target vessel revascularisation (tvr).The patient outcome was reported as resolved/recovered and the device remains implanted.The event was reviewed by veryan on 07-feb-23 and considered possibly related to the device.
Additional Manufacturer Narrative
Due to additional information received, the event type in section b.5.Was updated.The treated segment was also updated to reflect the superficial femoral artery (sfa) ostial to proximal third segment.
Event or Problem 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 6.0 x 100mm biomimics 3d (bm3d) stent to treat a denovo lesion of the superficial femoral artery (sfa) ostial to sfa proximal third in the left leg.A contralateral approach was used and the lesion was prepared using atherectomy and pre-dilated with percutaneous transluminal angioplasty (pta).The treated segment was post-dilated with pta.The site reported that on (b)(6) 2022, a restenosis of treated segment (target lesion) was identified.It was reported as not related to the device and not related to the procedure but due to a worsening of the pre-existing condition and intercurrent intervention.It was reported as target lesion related.The event occurred in the target limb and involved an in-stent target lesion restenosis.The left sfa ostial to the proximal popliteal segment was treated with a new bm3d bare metal stent placement, pta/standard balloon angioplasty and laser atherectomy on (b)(6) 2022.The event also involved a non-target lesion in the target vessel and a non-target vessel intervention.It was reported as a target lesion revascularisation (tlr) and target vessel revascularisation (tvr).The patient outcome was reported as resolved/recovered and the device remains implanted.The event was reviewed by veryan on (b)(6) 2023 and considered possibly related to the device.
Event or Problem Description
The patient was treated as part of the (b)(6) study.On the 22-nov-21, the patient was implanted with one 6.0 x 100mm biomimics 3d (bm3d) stent to treat a denovo lesion of the superficial femoral artery (sfa) ostial to sfa proximal third in the left leg.A contralateral approach was used and the lesion was prepared using atherectomy and pre-dilated with percutaneous transluminal angioplasty (pta).The treated segment was post-dilated with pta.The site reported that on (b)(6) 2022, a restenosis of treated vessel (target vessel) was identified.It was reported as not related to the device and not related to the procedure but due to a worsening of the pre-existing condition and intercurrent intervention.It was not target lesion related.A left sfa/ popliteal (pop) revascularization was done.The in-stent restenosis (isr) in the distal sfa and proximal pop (not biomimics stent) was treated with atherectomy and plain old balloon angioplasty (poba), as well as the native vessel proximal to the stent in the mid sfa.The left posterior tibial (pt) was also treated with atherectomy and poba.The left sfa middle third to the proximal popliteal segment was treated with a new bm3d bare metal stent placement, pta/standard balloon angioplasty and laser atherectomy on (b)(6) 2022.The event was not a target lesion revascularisation (tlr).It was a target vessel revascularisation (tvr).The patient outcome was reported as resolved/recovered and the device remains implanted.
Additional Manufacturer Narrative
As a result of the additional information received by the site, this event of restenosis is not related to the device or target lesion and does not meet the criteria of a mdr reportable event.

• 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, H91 V E0H; EI H91 VE0H
• Manufacturer Contact: alan mcdonagh ; unit 11 galway technology park; parkmore road; galway, H91VE-0H ; EI H91VE0H
• MDR Report Key: 16503500
• Report Number: 3011632150-2023-00030
• Device Sequence Number: 3352341
• Product Code: NIP
• UDI-Device Identifier: 05391526850459
• UDI-Public: (01)05391526850459(17)230312(11)210811(10)0000100305
• 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,Followup
• Report Date (Section B): 07/12/2023

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: 03/12/2023
• Device Model Number: 142122-10
• Device Catalogue Number: 142122-10
• Device Lot Number: 0000100305
• 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: 02/07/2023
• Supplement Date Received by Manufacturer: 03/14/2023; 06/14/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 04/12/2023; 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• 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; CLOPIDOGREL (PLAVIX)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American