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

Model Number 144700-12

Device Problems Fracture (1260); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 06/20/2022

Event Type  malfunction  

Manufacturer Narrative

A detailed review of the device history record associated with this lot did not reveal any issues that were deemed related to this complaint.The investigation is still ongoing.Any additional information received will be provided in a supplemental follow-up.

Event Description

On 20-jun-22 a us veryan representative was made aware of a patient who was implanted with one biomimics 3d stent ( 6 x 150mm) in the distal sfa to proximal popliteal of the right leg on (b)(6) 2020.It was reported that the implanted stent had a possible stent fracture on (b)(6) 2022.It required an additional intervention and extension in procedure time.

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 images provided were not the procedural angiographic image files but were taken via smartphone by the sales representative on site the same day.The biomimics 3d (bm3d) appears to have been deployed in an overlapped configuration proximally with another bm3d stent.Based on the review and the quality of the images it could not be determined whether the bm3d device had experienced any stent fracture.The investigation has been unable to determine the presence of a stent fracture in this case as the original angiographic images were not provided by the site.Original angiographic images are required to make a determination on whether a stent fracture did occur.Multiple attempts (3) have been made to request the angiographic imaging and additional information on the events but there has been no additional information provided.The complaint was categorised as "no fracture confirmed" and a root cause "unknown" was assigned.If any additional information 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 city, H91 V-E0H ; EI H91 VE0H
• MDR Report Key: 15050566
• MDR Text Key: 304124052
• Report Number: 3011632150-2022-00052
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850510
• UDI-Public: (01)05391526850510(17)220329(11)200828(10)0000050213
• 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: 09/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2022
• Device Model Number: 144700-12
• Device Catalogue Number: 144700-12
• Device Lot Number: 0000050213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention