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

Model Number 144700-12

Device Problems Activation, Positioning or Separation Problem (2906); Device Damaged by Another Device (2915); Physical Resistance/Sticking (4012); Premature Separation (4045)

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

Event Date 11/15/2021

Event Type  malfunction  

Manufacturer Narrative

The complaint investigation is ongoing.The device is being returned for evaluation.If further information regarding this event becomes available, or the investigation is concluded, a follow-up report will be submitted.

Event Description

On (b)(6) 2021, a physician at the (b)(6) medical center attempted to implant a biomimics 3d stent and failed.He had both left femoral and right popliteal access.He advanced the biomimics stent via femoral access to the distal right sfa/popliteal.When doing so, the popliteal sheath interacted with the biomimics delivery system, inhibiting deployment.When the physician realized this, damage was already done to the biomimics delivery system.He removed the system and called the veryan sales representative.There was a separation between the nosecone and delivery system catheter.He removed this separation and re-advanced the delivery system to the distal sfa/popliteal after retracting the popliteal sheath.He again tried to deploy.As he tried to "pin and pull" the delivery sheath retracted and stent came with- it would not unsheath.He removed the system again and tried to pin and pull on back table.After over a cm the stent was finally seen.The physician believes that the popliteal sheath entered the delivery system over nosecone and damaged stent and delivery system making it impossible to deploy.The patient was not harmed.

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 representative and images were provided.The delivery system was received at veryan with the distal tip fully retracted to the distal opening of the outer braid, with a full stroke length remaining.The stent had been fully deployed and was stored alongside the delivery system.A kink was noted in the support shaft.This is likely due to its packaging into the double bagged returns kit.Initial observation of the device found that there was a slight curl up in the device due to the cast from its use in procedure.No major kinks or damage were noted.The length of the outer braid was measured and was within the design specification requirements.All bonds on the returned device were inspected and were intact.No damage was noted to the distal tip.The proximal luer was pinned and stabilized and the bifurcation hub was retracted.No issues were found with outer braid retraction.No damage was noted on the stent stop, guidewire lumen or distal tip.The returned stent was examined and no issues were noted with the stent.During production of the biomimics 3d delivery system, space is left between the stent and the delivery system.This space is intentional, and its purpose is to mitigate against any inadvertent movement of the stent during the pre-deployment handling.Therefore, upon initiation of deployment it is required to retract the outer braid enough to remove these spaces in the delivery system prior to the release of the stent.In this case, this physician noted the outer braid was pulled back a distance without the stent releasing, which as described here is an anticipated occurrence in the deployment of a biomimics 3d stent.Following removal of the delivery system from the patient, the biomimics 3d stent was deployed on the benchtop without issue.It is important to note that the biomimics 3d stent was tracked over a 0.018" command guide wire to the deployment site where it failed to deploy.As per ifu-3 version 1.0, "the biomimics 3d stent is mounted on a 6f over-the-wire stent delivery system (sds) for use with a 0.035" guidewire." detailed inspection of the complaint device found no deficiencies with the device.No damage to either the delivery system or to the deployed stent was found.The investigation concludes that the reported complaint is not related to a deficiency of the device.The codes for investigation findings and conclusion have been updated from the initial report 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: 12907174
• MDR Text Key: 286520272
• Report Number: 3011632150-2021-00046
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850510
• UDI-Public: (01)05391526850510(17)221224(11)210525(10)90254
• 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

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/24/2022
• Device Model Number: 144700-12
• Device Catalogue Number: 144700-12
• Device Lot Number: 90254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/25/2021
• 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