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

Catalog Number	142122-11
Medical Device Problem Codes	Fracture (1260); Stretched (1601); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A detailed review of all the lot history records pertaining to the manufacture of the relevant stent and delivery system lot showed no issues that were deemed related to the complaint investigation.A single image was provided to the investigation team.The image was not an original angiographic image but was taken on a smartphone.It showed that the stent was deployed completely, as the radiopaque markers on the stent were visible in the image.The stent appeared elongated and the image confirmed that it was placed in overlap with another stent.The complaint was categorised as a "partial deployment, stent elongation" and a cause category of "insufficient information" was assigned.Veryan is aware that movement of the delivery system during deployment can lead to stent distortion (including elongation), in cases where the delivery system is not held in a fixed position during deployment.If any additional information is provided, a follow-up report will be submitted.Section b.5.Was updated, section d.6a.Was updated with the date implanted, sections g.6.And h.2.Reflect the type of report (follow-up 01) and the reason.Section h.6.Was aligned with the investigation conclusions and section h.11.Reflects the sections changed in this report.
Event or Problem Description
On (b)(6) 2024, a physician was using a biomimics 3d (bm3d) 7.0 x 100 mm stent and they reported that the stent fractured at the end, while deploying it to overlap with another previously placed stent in the superficial femoral artery (sfa).The complaint investigation was completed on (b)(6)2024, and one image was received and reviewed by the investigation team which confirmed that the stent was placed in a target lesion in the sfa of the patient's right leg.It was deployed fully and stent elongation was identified.No additional information was provided by the site despite multiple requests by veryan.The site confirmed that they had completed a computed tomography (ct) scan on the patient and would not provide any additional information until a follow-up angiogram/re-intervention had taken place.The site did not provide any timelines as to when this follow-up would be performed.
Additional Manufacturer Narrative
The investigation is in progress.Any additional information received will be provided in a follow-up/supplemental report.
Event or Problem Description
On (b)(6) 2024, a physician was using a biomimics 3d (bm3d) 7.0 x 100 mm stent and they reported that the stent fractured at the end, while deploying it to overlap with another previously placed stent in the superficial femoral artery (sfa).Veryan's date of awareness of this event was 20-sept-24.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Common Device Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL; 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: 20407922
• Report Number: 3011632150-2024-00052
• Device Sequence Number: 3579884
• Product Code: NIP
• UDI-Device Identifier: 05391526850466
• UDI-Public: (01)05391526850466(17)250303(11)230803(10)0000243774
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 12/11/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/03/2025
• Device Catalogue Number: 142122-11
• Device Lot Number: 0000243774
• 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: 09/20/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown