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

Catalog Number	142122-14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Pain (1994); Restenosis (4576)
Date of Event	06/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is related to mdr number 3011632150-2023-00104.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, leg pain/claudication and ischemia 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
This report is related to mdr number 3011632150-2023-00104.The patient was treated as part of the mimics 3d usa post-market observational study.On the (b)(6) 2022, the patient was implanted with one biomimics 3d (bm3d) stent, a 6.0 x 150 mm stent which was used to treat a restenotic lesion of the superficial femoral artery (sfa) middle third in the left leg.A retrograde approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was also post-dilated with pta.On (b)(6) 2022 an additional 6.0 x 125 mm bm3d stent (the subject of this report) was placed in the sfa middle third to proximal popliteal to treat a restenosis.The site reported that on (b)(6) 2023, a restenosis of treated segment (target lesion) was identified.The device relationship was reported as possibly related and the procedure relationship was reported as not related.It was reported as target lesion related and required percutaneous intervention.The patient presented for her 12-month follow-up visit on (b)(6) 2023.She had recurrent claudication symptoms and ischemic rest pain in her left leg.An ultrasound showed some areas of in-stent restenosis as well as a decreased ankle brachial index (abi).On (b)(6) 2023 an angiogram was performed on her left leg which showed a stent present about 6 cm below the origin of the sfa.There was a high-grade stenosis just above the stent and diffuse in-stent restenosis was noted in the stented segments of the vessel which extended from the sfa proximal to the proximal popliteal artery a short distance above the knee.The patient had pta/standard balloon angioplasty and laser atherectomy on the sfa proximal third to distal popliteal on (b)(6) 2023.Completion arteriogram showed brisk flow through the entire treated segment with no evidence of residual stenoses.The patient was discharged in a stable condition.The outcome was reported as resolved/recovered.It was reported as a target lesion revascularisation (tlr) and target vessel revascularisation (tvr).The devices remain implanted.
Additional Manufacturer Narrative
This report is related to mdr number 3011632150-2023-00104.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, leg pain/claudication and ischemia 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.5.Was updated with the additional information received.Section d.6a.Was updated to reflect the 21-nov-22.Sections g.6.And h.2.Were updated to reflect the type of the report (follow-up 01) and the reason, and section h.11.Was updated to reflect the sections that have changed.
Event or Problem Description
This report is related to mdr number 3011632150-2023-00104.The patient was treated as part of the mimics 3d usa post-market observational study.On (b)(6) 2022, the patient was implanted with one biomimics 3d (bm3d) stent, a 6.0 x 150 mm stent which was used to treat a restenotic lesion of the superficial femoral artery (sfa) middle third in the left leg.A retrograde approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was also post-dilated with pta.On (b)(6) 2022 an additional 6.0 x 125 mm bm3d stent (the subject of this report) was placed in the sfa middle third to proximal popliteal to treat a restenosis.The site reported that on (b)(6) 2023, a restenosis of treated segment (target lesion) was identified.The device relationship was reported as possibly related and the procedure relationship was reported as not related.It was reported as target lesion-related and required percutaneous intervention.The patient presented for her 12-month follow-up visit on (b)(6) 2023.She had recurrent claudication symptoms and ischemic rest pain in her left leg.An ultrasound showed some areas of in-stent restenosis as well as a decreased ankle-brachial index (abi).On the (b)(6) 2023 an angiogram was performed on her left leg which showed a stent present about 6 cm below the origin of the sfa.There was a high-grade stenosis just above the stent and diffuse in-stent restenosis was noted in the stented segments of the vessel which extended from the sfa proximal to the proximal popliteal artery a short distance above the knee.The patient had pta/standard balloon angioplasty and laser atherectomy on the sfa proximal third to distal popliteal on (b)(6)2023.Completion arteriogram showed brisk flow through the entire treated segment with no evidence of residual stenoses.The patient was discharged in a stable condition.The outcome was reported as resolved/recovered.It was reported as a target lesion revascularisation (tlr) and target vessel revascularisation (tvr).The devices remain implanted.Additional information was reviewed by veryan on 15-apr-24 which included the clinical events committee (cec) adjudication of this event.It was determined that it was not related to the study device due to the previous manipulations of the vessel that were part of the previous tlrs to treat the events.This was the third restenosis in the sfa middle third segment where the study stent was placed.It was the second restenosis event of the sfa middle third to the proximal popliteal segment where the non-study stent was placed.It was considered not related to this stent.The first and second restenoses of the study stented segments were reported as mdrs 3011632150-2022-00116 and 3011632150-2023-00044 and the first non-study stent restenosis was reported as mdr 3011632150-2023-00045.

• 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: 17496589
• Report Number: 3011632150-2023-00105
• Device Sequence Number: 19468748
• Product Code: NIP
• UDI-Device Identifier: 05391526850480
• UDI-Public: (01)05391526850480(17)230929(11)220228(10)0000136622
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P180003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 05/13/2024

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: 09/29/2023
• Device Catalogue Number: 142122-14
• Device Lot Number: 0000136622
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2022
• 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
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White