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

Model Number 144700-12

Device Problems Break (1069); Failure to Advance (2524); Activation Failure (3270); Physical Resistance/Sticking (4012)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2021

Event Type  malfunction  

Manufacturer Narrative

The complaint investigation is ongoing.The device is being returned for evaluation.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 report will be submitted.

Event Description

On the (b)(4) 2021 a patient with extremely tortuous vessel anatomy and calcification was being treated with a biomimics 3d vascular stent system.The physician pre-dilated with a sterling 5x220 with low inflations and then with high inflation pressures because he knew that the anatomy was not ideal.He used an access point in the groin and used an up and over approach.His approach for crossing the occlusion was true lumen from the ostium in the sfa and then believed he went subintimal back to true lumen.He met a lot of resistance towards the distal end of his target region.He could not advance the biomimics delivery system any further.He then proceeded to deploy the stent, approx.8mm was deployed.Then he started to encounter resistance while pinning and pulling the outer carrier sheath back to the blue hub (wire port).He then lost all ability to push the device due to anatomy and tortuosity from iliacs and superficial femoral artery (sfa)/ popliteal artery (pop).What he observed was the outer carrier sheath elongated and the stent never exited outside the distal end of the carrier sheath.He met a lot of resistance and this is when the stent broke.Part of the broken stent remained in the anatomy.Everything was removed and as he had a wire in place, he then proceeded to repeat a balloon dilation of the vessel and deliver a non biomimics stent to finish the procedure.The patient had palpable pulses and the case was finished.

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 smartphone images were provided.A contralateral approach was used and the vessel anatomy was described as extremely tortuous.It was not possible to reach the intended target site due to the resistance and deployment occurred towards the distal end of the target site.Despite the resistance encountered upon initiation of deployment, the physician continued to deploy the stent which is not in accordance with the directions in the ifu which states that the delivery system should be withdrawn carefully without deployment of the stent in such cases of resistance.The images provided were not the original procedural angiographic image files.The images showed evidence of calcification of the sfa and the piece of stent (containing 5 crowns) that remained in the vessel following removal of the device.The returned device was evaluated and the stent struts were protruding from the distal end.There was also a slight tear in the distal outer braid which also extended to the radioopaque marker band.This is highly likely to be related to the resistance imposed on the device during removal of the delivery system following partial deployment of the stent.All bonds as well as distal tip of the device were intact.The outer braid was elongated.This is likely due to the friction which may have been created between delivery system components and/or the delivery system and the introducer sheath due to the tortuous vessel anatomy.This in turn can lead to partial deployment.Some crowns of the stent remaining in the returned device were deployed on the bench top without any noteworthy resistance.The stent could not be fully deployed due to the nature of the elongation of the outer braid.The root cause of the complaint was identified as being due to the patient's anatomy.The complaint is not related to a deficiency of the device.The adverse event coding (section h.6.) has been updated based on the findings and conclusions following completion of the investigation.If further information regarding this event becomes available, a follow-up report will be submitted.

Manufacturer Narrative

This mdr report is related to mdr number 3011632150-2021-00043 and mdr supplemental 3011632150-2021-00043_01.Following completion of the investigation associated with this reportable event the original angiographic images were received by veryan and reviewed.The images confirmed that the patient's iliac arteries were tortuous.In this case the images also displayed an acute aortic bifurcation angle.This confirmed that the vascular anatomy was particularly difficult.It was noted that that the target site was heavily calcified.The condition of the vessel at the proximal and distal ends of the superficial femoral artery were heavily calcified and there was a poor response to pre-dilation.It was also confirmed that the physican went subintimal during the procedure which would be an additional factor that would be likely to contribute to the increased deployment force and resistance felt during the procedure, and which can lead to partial deployment.The images also confirmed that there was very limited space for stent deployment.A small portion of the lumen remained patent.Additional vessel preparation was required prior to deploying the competitor stent over the portion of biomimics 3d stent that remained in the vessel.The information provides additional detail to support the previously reported findings and remain unchanged.These findings remain unchanged.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 city, H91 V-E0H ; EI H91 VE0H
• MDR Report Key: 12851764
• MDR Text Key: 281105969
• Report Number: 3011632150-2021-00043
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850510
• UDI-Public: (01)05391526850510(17)230121(11)210622(10)0000091470
• 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,Followup
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 01/21/2023
• Device Model Number: 144700-12
• Device Catalogue Number: 144700-12
• Device Lot Number: 0000091470
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/22/2021
• 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
• Patient Outcome(s): Other