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

Model Number 142122-09

Device Problems Fracture (1260); Material Deformation (2976)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/01/2021

Event Type  malfunction  

Manufacturer Narrative

The complaint investigation is ongoing.The device was not returned for evaluation.Angiography imaging will be reviewed as part of the investigation.If further information regarding this event becomes available, or the investigation is concluded, a followup report will be submitted.

Event Description

On (b)(6) 2021, a physician reported to a veryan representative information about a stent fracture identified in a patient who was implanted in (b)(6) 2021.The fracture was identified during a follow-up angiogram on (b)(6) 2021.The veryan representative received additional information on 02 november 2021 stating that angioplasty and placement of another stent inside the biomimics was performed.The stent remains implanted.Angiographic imaging is available.It is not known if the physician believes the incident is related to the device.

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.The investigation included communication/interviews and review of smartphone images provided as well as additional information from the reporting physician.The images were not the original angiographic images.The originals were requested but the clinical site clarified that the original images would not be made available.Based on a review of the images that were available, it was possible to detect a distorted stent pattern in the biomimics 3d stent.Determination of a stent fracture and the extent of stent pattern distortion was not possible from the images provided.Additional information from the physician highlighted that the biomimics stent was implanted using a contralateral approach, balloon angioplasty was performed prior to stent placement.There were two stents implanted at the index procedure, the biomimics 3d stent was placed distally to the viabahn stent.The physician also clarified that the procedure was not out of the ordinary and there were no issues to report.The complaint was categorised as a distorted stent pattern and a root cause could not be determined.The complaint is not related to a deficiency of the device.Any additional information provided will be provided in a follow-up report.Section h.6.Adverse event coding has been updated to reflect the findings and conclusion of the investigation.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Type of Device: 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, H91 V-E0H ; EI H91 VE0H
• MDR Report Key: 12851921
• MDR Text Key: 281091999
• Report Number: 3011632150-2021-00045
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850442
• UDI-Public: (01)05391526850442(17)220314(11)200813(10)48415
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2022
• Device Model Number: 142122-09
• Device Catalogue Number: 142122-09
• Device Lot Number: 48415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2021
• Initial Date FDA Received: 11/22/2021
• Supplement Dates Manufacturer Received: 12/21/2021
• Supplement Dates FDA Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention