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

Catalog Number	144700-05
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Limb Pain (4836)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is in progress.If any additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
On 25-mar-25 a veryan sales specialist received information that reported that a patient presented with a cold leg after 5 x 150mm biomimics 3d (bm3d) stent was implanted on (b)(6) 24.An angio was taken to verify that the stent had fractured in the right femopopliteal segment and was the cause of the occlusion that blocked flow to the lower extremity.The patient was administered tpa for 24 hours and further intervention was required to open up occluded stent and repair fractured stent.
Additional Manufacturer Narrative
Complaint complete and event remains reportable.A detailed review of all the lot history records pertaining to the relevant stent and delivery system lots showed no issues that were deemed related to the complaint investigation.Based on the feedback in this case, as well as the review of the complaint images, it is understood that a type 2 stent fracture; multiple single strut fractures, had occurred.Potential root cause: physiological loading although there is some movement in the area of the separated stent struts the artery does not seem to be tortuous or kinked in this area prior to deployment, so movement is an unlikely explanation.As part of this investigation, a query was made to the complaint site regarding the lifestyle of the patient.Information regarding the patient lifestyle was obtained by veryan us regional sales director greg wagg.Feedback from the site explained that this patient does in fact have an active lifestyle due to their profession which requires movement and considerable time spent squatting.It was also noted that the complaint physician; dr miller, also shared the opinion that the patient's lifestyle would be a fitting root cause for the stent fracture seen in this case.Based on the information that is available in this case, and the medical input received from veryan's medical officer, the root cause of the noted stent fracture in this case is physiological loading, and is not related to a device deficiency.As noted by both the veryan medical officer, and the complaint physician, the lifestyle of the patient would have excerpted additional stress on the biomimics 3d stent after its implantation, which would have increased the risk of stent fracture, which ultimately occurred in this case.The root cause of this complaint is likely physiological loading, as the lifestyle of the patient would have excerpted additional stress on the biomimics 3d stent after its implantation.The complaint was categorised as "stent fracture (type ii)" and "physiological loading.The reported complaint is not related to a deficiency of the device.Section g.6 and h.2 were updated to reflect the type of report (follow up 01) and the reason and section h.6 and h.11 were updated to reflect the conclusions of the investigaion and reflected the sections changed in this report.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Common Device Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL LIMITED; block 5; parkmore east business park; galway, H91 V 0TX; EI H91 V0TX
• Manufacturer Contact: caroline grealish ; block 5; parkmore east business park; galway, H91 V-0TX ; EI H91 V0TX
• MDR Report Key: 21899466
• Report Number: 3011632150-2025-00008
• Device Sequence Number: 4059813
• Product Code: NIP
• UDI-Device Identifier: 05391526850503
• UDI-Public: (01)05391526850503(17)240816(11)230116(10)0000193475
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P180003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/16/2024
• Device Catalogue Number: 144700-05
• Device Lot Number: 0000193475
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2023
• 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
• Patient Sex: Unknown