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

Catalog Number	142122-14
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Activation Failure (3270)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, a physician at a us healthcare facility was using a 6.0 x 125 mm biomimics 3d device and it was reported that it partially deployed.There was no impact to the patient.
Additional Manufacturer Narrative
The investigation is in progress and any additional information will be provided in a follow-up supplemental report.
Additional Manufacturer Narrative
A detailed review of all the lot history records related to lot number 164135 was performed; there were no issues identified that were deemed related to the complaint investigation.A detailed review of all the lot history records related to the lot number associated with this device was performed; there were no issues identified that were deemed related to the complaint investigation.A questionnaire was sent to the complaint site in order to obtain more procedural information and information on the events reported.However, no response from the site was returned despite multiple efforts made.A single image was provided to the investigation.These images were not original angiographic images but were taken via smartphone.It displayed the proximal sfa of the patient's left leg in which a biomimics 3d stent was shown.The radiopaque markers at the proximal and distal ends were identifiable and therefore it appears that the entire stent was fully deployed.The stent does not display any clear points of distortion or stent fracture.The image does show that roughly half of the stent on the proximal side has not expanded fully.The distal portion of the stent was expanded fully.It appeared that the proximal portion of the stent has not been post-dilated, however, this cannot be confirmed due to insufficient information received.The complaint investigation was categorised as "insufficient information" and a root cause category could not be assigned as a result.It could not be determined if the complaint was related to a deficiency of the device.

• 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: 18375287
• Report Number: 3011632150-2023-00145
• Device Sequence Number: 20760809
• Product Code: NIP
• UDI-Device Identifier: 05391526850480
• UDI-Public: (01)05391526850480(17)240305(11)220805(10)0000164135
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P180003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/19/2024

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: 03/05/2024
• Device Catalogue Number: 142122-14
• Device Lot Number: 0000164135
• 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: 12/08/2023
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown