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

Catalog Number 144700-19

Device Problems Difficult or Delayed Positioning (1157); Stretched (1601); Difficult or Delayed Activation (2577)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/23/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.The complaint investigation is ongoing.If further information regarding this event becomes available, a follow-up/supplemental report will be submitted.

Event Description

It was reported that during a procedure to treat a lesion in the femoropopliteal artery, advancement of the biomimics 3d stent delivery system through a tight aortic bifurcation was necessary to reach the target lesion.A phillips phoenix light support wire.014" and medtronic.014" spider filter wire were used during the procedure.The balloon and atherectomy devices used prior to stent implantation were reported as passing the tight aortic bifurcation and into position but with difficulty.During deployment of the biomimics 3d stent, the physician attempted a number of times (4-5 attempts) to deploy the stent but reported difficulty starting the deployment.He repeatedly had to reposition so that deployment would occur at the target landing zone.Eventually, the stent was deployed successfully without incident.Following successful deployment, the stent was reported as having a more "open" cell appearance and had become elongated by 10mm.The stent was post dilated with balloon angioplasty and a satisfactory result was reported.There was no adverse patient impact reported, and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device identifier part of the udi number has been corrected from the previous value to the correct number (b)(4).

Manufacturer Narrative

The device history review was completed.There were no issues identified that could have contributed to the reported complaint.The lot met the relevant in-process monitoring acceptance criteria.Th information received during the investigation was limited, despite multiple requests made by veryan's complaint investigation team in the course of the investigation.The conclusions were reliant on the information provided in the "initially" reported complaint, which included reference to a challenging tortuous anatomy and tight aortic bifurcation angle.These conditions are also reported as presenting difficulty when positioning devices used in preparing the target lesion prior to biomimics 3d placement.Resistance felt during deployment is likely to have been caused by the tortuous anatomy and tight bifurcation angle which would have created conditions where there were increased frictional forces being applied to the delivery system as well as between the delivery system and the guide/introducer sheath.The stent elongation which was reported may have been as a result of the technique employed by the user.Although there is not enough information to be able to conclude this as a definite cause, stent elongation can result if the delivery system is moved during deployment as stated in the biomimics 3d instructions for use.There is no indication of a product quality issue with respect to the design, manufacture or labelling of the device.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, H91 V E0H; EI H91 VE0H
• MDR Report Key: 11884117
• MDR Text Key: 253258605
• Report Number: 3011632150-2021-00020
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850268
• UDI-Public: (01)05391526850268(17)220417(11)200916(10)0000052116
• Combination Product (y/n): N
• PMA/PMN Number: P180003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/13/2021

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: 04/17/2022
• Device Catalogue Number: 144700-19
• Device Lot Number: 0000052116
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2021
• Initial Date FDA Received: 05/26/2021
• Supplement Dates Manufacturer Received: 06/08/2021; 06/08/2021
• Supplement Dates FDA Received: 07/02/2021; 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other