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

Model Number 144700-12

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

Patient Problems Aneurysm (1708); Pseudoaneurysm (2605)

Event Date 10/28/2021

Event Type  malfunction  

Event Description

On 28 oct 2021, a veryan sales representative was made aware of a stent fracture of a biomimics 3d stent in the distal superficial femoral artery to proximal popliteal artery (sfa/ppa).The event occurred on the same day.The device fractured resulting in pseudoaneurysm.The device remains implanted angiographic imaging is available.The physician believes that the incident is related to the device.No other information is available at this time.

Manufacturer Narrative

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

Event Description

On (b)(6) 2021, a veryan sales representative was made aware of a stent fracture of a biomimics 3d stent in the distal superficial femoral artery to proximal popliteal artery (sfa/ppa).The event occurred on the same day.The device fractured resulting in pseudoaneurysm.The device remains implanted and smartphone angiographic imaging is available.The physician believes that the incident is related to the device.As part of the investigation of this complaint, images provided were reviewed but no evidence of a stent fracture could be found.It was observed that the stent was implanted in a region where the distal end of the stent was positioned below the distal cortical margin of the femur which is outside the biomimics 3d approved indications for use.There was evidence of a distorted stent pattern.The images were not the original angiographic imaging files and the extent of stent pattern distortion was not possible to determine.An aneurysm was also observed in the proximity of the stent pattern distortion but it is not possible to determine the cause of the aneurysm or if it is related to the distorted stent pattern.If the aneurysm occurred prior to the distorted stent pattern it could have created atypical conditons (e.G.Vessel diameter widens) and the stented region becomes unsupported when subject to physiological loading.

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.Further information on the case was provided including smartphone images.These were not the original procedural angiographic image files.The original images were requested but these have not yet been received.The images provided were reviewed and confirmed that the distal edge of the stent was positioned below the cortical margin of the femur which would be outside the approved indications for use.The images did not confirm the presence of any stent fracture(s), however there was evidence of a distortion of the stent pattern but the extent of this could not be determined from the images.There was also evidence of an aneurysm which was located in the proximity of the distorted stent pattern.In the absence of the original angiographic images or other procedural information, it is not possible to determine the cause of the aneurysm.It is possible that if the aneurysm occurred prior to the distortion of the stent pattern, it could have created atypical conditions (e.G.Enlarged vessel diameter) which would have caused an unsupported stent when subjected to physiological loading could lead to deformation.The cause categories assigned are unknown and user as a result of the positioning outside of the stents's approved indication.The type of event (section b.1.) has been updated to include adverse event and product problem.The description of the event (section b.5.) and the adverse event coding (section h.6.) have been updated based on the updated information obtained following completion of the investigation.If further information regarding this event becomes available, a follow-up report will be submitted.

• 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: 12851920
• MDR Text Key: 283086988
• Report Number: 3011632150-2021-00044
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850510
• UDI-Public: (01)05391526850510(17)220702(11)201201(10)0000061412
• 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: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2022
• Device Model Number: 144700-12
• Device Catalogue Number: 144700-12
• Device Lot Number: 0000061412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/22/2021
• Supplement Dates Manufacturer Received: 12/16/2021
• Supplement Dates FDA Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• 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; Hospitalization