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	08/21/2023
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 interventions and claudication/leg 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 male patient was implanted with one 6.0 x 150mm biomimics 3d stent (bm3d) on an unspecified date in (b)(6) to treat a de novo lesion of the superficial femoral artery (sfa) middle third in the left leg.On the (b)(6) 2023, the patient arrived to the clinic and presented with left leg pain.An event of restenosis was identified during an ultrasound.The restenosis rate was approximately 90%.In (b)(6) 2023, endovascular treatment (evt) was performed.An angiogram showed the event was an in-stent restenosis (isr).Plain old balloon angioplasty (poba) was performed using a nc balloon, and the inside of the stent was dilated with a drug coated balloon (dcb).The patient's progress is being monitored.

• 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: 18208240
• Report Number: 3011632150-2023-00136
• Device Sequence Number: 12612786
• Product Code: NIP
• UDI-Device Identifier: 05391526850510
• UDI-Public: (01)05391526850510(17)231107(11)220408(10)0000144053
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P180003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/27/2023

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: 11/07/2023
• Device Catalogue Number: 144700-12
• Device Lot Number: 0000144053
• 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: 11/01/2023
• Initial Report FDA Received Date: 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2022
• 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: LIXIANA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male