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

Catalog Number 144700-19

Device Problems Fracture (1260); Material Separation (1562); Stretched (1601); Difficult to Advance (2920); Activation Failure (3270); Physical Resistance/Sticking (4012)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/06/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation into this event is in progress.Any additional information received will be submitted in a follow-up supplemental report.

Event Description

On (b)(6) 2024, a physician was using a biomimics 3d (bm3d) 7.0 x 150 mm stent system.It was reported that the system had some resistance going through the sheath but the physician was able to advance it to the target site.The first two centimetres (2 cm) of the stent deployed without issue.It became increasingly difficult to deploy the stent and significant resistance was experienced.The physician reported that this led to a "snap" that was felt afterward.The physician reported that pulling back on the deployment mechanism did not translate to any further deployment of the stent.At this point the sheath was advanced over the entire bm3d stent deployment system and it was used to capture the stent.During this process, 2 cm of the stent broke off and remained in the vessel.After removal of the bm3d system, the portion of stent that remained was crossed with a 0.035" wire and a competitor stent was deployed and post-dilated to affix the portion of the bm3d stent against arterial flow.The completion angiography showed good flow through the vessel.There was no impact to the patient reported.It was reported that the physician does not believe the event was related to the device.

Manufacturer Narrative

A detailed review of all the lot history records pertaining to the relevant stent and delivery system lot showed no issues that were deemed related to the complaint investigation.The complaint device was returned for evaluation.It was returned with a severe cast and separation of the bifurcation hub from the outer braid due to the bond failure.There were fractured crowns protruding from the distal end of the outer braid.A completely separated section of the stent was also returned alongside the complaint device.Radiopaque marker damage was observed under microscope which coincided with the protruding stent crowns which were considered to be the cause of this damage.There was no damage to the distal tip.The outer braid was elongated.The remaining bonds of the device were intact.The outer braid to bifurcation hub bond was examined.The presence of manufacturing indicators indicated that the complaint device was manufactured as intended.An attempt to deploy the remaining portion of the stent was made and multiple crowns were released with little resistance, but the stent could not be released fully as the outer braid reached the bifurcation hub and proximal pin luer.No defects were noted in the portion of the stent that was deployed.The "snap" that was reported by the physician was understood to be the separation of the outer braid from the bifurcation hub.This bond failure was suggestive of a high deployment force encountered during deployment.The elongated outer braid was also evidence that supports this high deployment force that was present.This partial deployment was caused by the increased resistance during deployment which led to a high deployment force and failure of the bifurcation hub to outer braid bond.The removal of the delivery system led to the fracture of the portion of the partially deployed stent.In this case, the physician reported that there was resistance during advancement of the device through the tight aortic bifurcation but they continued to advance to the target site.This is contrary to the warnings in the instructions for use (ifu) which state that in such cases of resistance, the device should be withdrawn without deploying the stent, as resistance can lead to damage of the device, stent or vessel.Therefore, the user was considered one of the contributory causes that led to the deployment issue in this case.The high deployment force was believed to be caused by the challenging anatomical conditions of the vessel i.E.The tight aortic bifurcation reported and the severely tortuous iliac arteries.The vessel was also reported as having stenosis and calcification throughout.These conditions may have led to friction between the device components and also between the device and the access/guide sheath during deployment.Angiographic images were not provided, so the anatomical conditions of the vessel cannot be fully established.Veryan is aware that challenging anatomical conditions can contribute to increased resistance and may lead to delivery system damage which can lead to partial deployment of the stent as seen with this case.This complaint was categorised as a partial deployment, stent fracture and the cause categories assigned were user and anatomy.The complaint was not related to a deficiency of the device.Section b.5.Was updated with additional information, section d.9.Was updated with the date of device return, sections g.6.And h.2.Were updated to reflect the type of report (follow-up 01) and the reason.Section h.3.Was updated to yes.Section h.6.Was updated to align with the investigation conclusions and section h.11.Was updated with the conclusions of the investigation and summarised the sections of this report that were changed.

Event Description

On (b)(6) 2024, a physician was using a biomimics 3d (bm3d) 7.0 x 150 mm stent system.It was used to treat the superficial femoral artery (sfa).The target vessel was reported to have 60% stenosis with calcification present throughout.The vessel anatomy also had a tight aortic bifurcation and severe tortuosity in the iliac arteries.A contralateral approach was used using a 6 fr access sheath and a 0.014" glidewire advantage guidewire.The physician prepared the vessel using cardiovascular systems inc.(csi) atherectomy and balloon angioplasty.The device was flushed as per the instructions for use (ifu).There was resistance felt during advancement of the device through the aortic bifurcation towards the target site.The physician reached the target site and successfully released 2 cm of the stent.At this point the deployment force increased and significant resistance was experienced.The physician continued with deployment of the stent leading to the failure of the bifurcation hub to outer braid bond and separation of both components.At this point the physician decided to advance the sheath over the entire bm3d delivery system and it was used to capture the stent.During this process, a portion of the stent fractured and remained in the vessel after removal of the bm3d delivery system.There was no additional vessel preparation required.The portion of stent that remained was crossed with a 0.035" wire and a competitor stent was deployed without issue and post-dilated with balloon angioplasty.The completion angiography showed good flow through the vessel.There was no impact to the patient reported and there were no adverse effects on the patient as a result of the procedure.The outcome was reported as favourable.The events led to a prolonged procedure.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Type of Device: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL LTD; block 5; parkmore east business park; galway, H91 V 0TX; EI H91 V0TX
• Manufacturer Contact: alan mcdonagh ; block 5; parkmore east business park; galway, H91 V-0TX ; EI H91 V0TX
• MDR Report Key: 19039464
• MDR Text Key: 339320838
• Report Number: 3011632150-2024-00016
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850527
• UDI-Public: (01)05391526850527(17)240827(11)230127(10)0000194821
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/28/2024

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 Catalogue Number: 144700-19
• Device Lot Number: 0000194821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2023
• 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