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

Catalog Number	144700-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Restenosis (4576)
Date of Event	12/21/2023
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 had intermittent claudication in the lower limbs since autumn 2022 and was referred to the hospital on (b)(6) 2023 for further examination as the patient's ankle-brachial index (abi) values were low as recognised by the previous physician.Endovascular treatment (evt) was scheduled because a significant stenotic lesion was found in the right femoral artery via vascular ultrasound.On (b)(6) 2023 the patient was admitted to hospital for evt.The patient consented to treatment that involved the implantation of a biomimics 3d (bm3d) stent.The lesion was prepared with plain old balloon angioplasty (poba) on the right femoral artery and a bm3d 6.0 x 150 mm stent was placed.The procedure was completed without any complications.The patient was started on 200mg cilostazol tablets orally per day on (b)(6) 2023.They were discharged on (b)(6) 2023 after a good post-operative course.On (b)(6) 2023, 30 days after the procedure, the patient visited the hospital as scheduled.They had no intermittent claudication symptoms.The blood flow in the lower limbs was good according to abi and duplex ultrasound (dus).On (b)(6) 2023, the patient visited the hospital 6 months after the procedure with mild intermittent claudication symptoms.A vascular ultrasound examination revealed a restenosis within the right femoral artery stent.After consultation with the patient, admission for evt was scheduled for (b)(6) 2024.On (b)(6) 2024, evt was performed for restenosis within the right femoral artery stent.Pre-dilation was successful with an ultrascore 6.0 x 150mm balloon, and the procedure was completed by applying an in.Pact admiral 6.0 x 200 mm drug-coated balloon.On (b)(6) 2024, the patient was discharged from the hospital after a good postoperative course.The physician/reporting institution determined that there was a causal relationship between the implanted stent, the target lesion and the restenosis event in the right femoral arterial stent.It was considered serious as it led to admission of the patient to hospital for evt purposes.

• 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: 18729871
• Report Number: 3011632150-2024-00003
• Device Sequence Number: 7187029
• Product Code: NIP
• UDI-Device Identifier: 05391526850510
• UDI-Public: (01)05391526850510(17)240506(11)221006(10)0000176703
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P180003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/19/2024

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: 05/06/2024
• Device Catalogue Number: 144700-12
• Device Lot Number: 0000176703
• 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: 01/24/2024
• Initial Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2022
• 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: CILOSTAZOL.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 50 KG