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

Model Number	142122-14
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient had a 6 x 125mm biomimics 3d stent implanted in the left sfa on (b)(6) 2021.The patient was brought back for angiogram and the stent was reported as fractured.The physician then relined the fractured 6 x 125 biomimics with a non biomimics 3d stent and the patient is doing well.
Additional Manufacturer Narrative
The investigation into this event is in progress.When further information regarding this event becomes available, a follow-up supplemental report will be submitted.
Additional Manufacturer Narrative
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.As part of the investigatiion, a list of questions were sent to the physician involved in the case to obtain more information on the procedure.The target site was the right adductor canal of the sfa.A contralateral approach was used and the target site was prepared using laser atherectomy and balloon angioplasty.The vessel anatomy was considered normal and there were no issues crossing the aortic bifurcation.There was no drug coated balloon used.There was no adverse event associated with the deployment.On a follow-up visit on (b)(6) 2022 (6 months post implantation) an occlusion was identified in an unspecified segment of patient's vessel and it was on this date the stent fracture was noted.The segment of vessel which was occluded is not reported.The physician did not report the type of fracture.Despite multiple attempts (3) to obtain more information no further information was provided.A review of angiographic images taken on a smartphone by the sales representative and were not the original procedural dicom images was conducted as part of the investigation.A slight stent distortion is present towards the distal end of the stent although the reported stent fracture cannot be confirmed.The extent of the stent distortion cannot be determined from the images provided and a root cause cannot be established.The complaint has been categorised as a distorted stent pattern and a root cause of unknown assigned.Section b.5.Has been updated as well as section h.6.If any additional information is made available it will be provided in a supplemental follow-up report.
Event or Problem Description
The patient had a 6 x 125mm biomimics 3d stent implanted in the right sfa on (b)(6) 2021.The patient was brought back for angiogram on (b)(6) 2022 and an occlusion in an unspecified vessel segment was identified and the stent was reported as fractured.The physician then relined the fractured 6 x 125mm biomimics with a non biomimics 3d stent and the patient is doing well.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Common Device Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL LTD; unit 11 galway technology park; parkmore road; galway city, H91 V E0H; EI H91 VE0H
• Manufacturer Contact: alan mcdonagh ; unit 11 galway technology park; parkmore road; galway city, H91 V-E0H ; EI H91 VE0H
• MDR Report Key: 14692562
• Report Number: 3011632150-2022-00036
• Device Sequence Number: 5176542
• Product Code: NIP
• UDI-Device Identifier: 05391526850480
• UDI-Public: (01)05391526850480(17)220813(11)210112(10)0000066598
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P180003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2022

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: 08/13/2022
• Device Model Number: 142122-14
• Device Catalogue Number: 142122-14
• Device Lot Number: 0000066598
• 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: 05/18/2022
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2021
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown