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

Model Number 144700-19

Device Problems Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012); Difficult or Delayed Separation (4044)

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

Event Date 07/15/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The representative reported that the physician experienced significant deployment resistance during usage of one biomimics 3d stent system (7 x 150mm).It became easier to deploy after the initial release.Upon fully retracting the deployment mechanism, the stent was still partially captured in the delivery system by 2cm.The physician had to manoeuvre the deployment system back and forth in order to release the stent.There was no reported impact to the patient.

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 lot met the relevant in-process monitoring acceptance criteria.Further information on the case was provided by the relevant veryan sales representatives.In this case the anatomy of the patient was severely tortuous, with a tight bifurcation angle to cross.The physician was aware of the difficulty presented by the patient anatomy, and that the case could cause difficulty for the deployment of the 7x150 mm biomimics 3d device.A cross-over approach was used, and upon initiation of deployment the physician experienced resistance.However, the physician did release the distal stent crown and was able to deploy the majority of the stent length.At this point, the bifurcation hub had been fully retracted to the proximal pin luer, but a small portion of the stent remained in the outer braid of the delivery system.It was highlighted that the physician was not overly concerned about the situation and understood that this scenario is a possibility when deploying longer stents.To complete the deployment the physician manipulated the stent delivery system to free the remaining stent crowns.The stent was deployed successfully.Although the investigation team did not receive any angiographic imaging for review as part of this investigation despite multiple requests, and the device was not returned for analysis, they have concluded that a possible root cause of this complaint is the challenging anatomical condition of the patient.Despite resistance being immediately noted by the physician upon initiation of deployment, the attempt to release the stent was continued.It is important to note that the biomimics 3d stent ifu-3 version 3.0 indicates the following warning statement: "warning: if unexpected resistance is felt at the start of the deployment, do not force the movement of the bifurcation luer; instead carefully withdraw the sds without deploying the stent." the coding has been updated to reflect completion of the investigation.This complaint is not related to a deficiency of the device.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: 12299676
• MDR Text Key: 265767542
• Report Number: 3011632150-2021-00039
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850527
• UDI-Public: (01)05391526850527(17)220910(11)210209(10)0000063547
• 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
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2022
• Device Model Number: 144700-19
• Device Catalogue Number: 144700-19
• Device Lot Number: 0000063547
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other