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

Catalog Number 144700-19

Device Problems Fracture (1260); Stretched (1601); 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 05/31/2023

Event Type  malfunction  

Manufacturer Narrative

This is related to user facility report number: (b)(4).The reported event is currently being investigated and any additional information received will be provided via a mdr supplemental report.

Event Description

This is related to user facility report number: (b)(4).On (b)(6) 2023, the superficial femoral artery (sfa) was prepared using shockwave treatment via a contralateral approach using a 7f access sheath and 0.035" guidewire.There was mild calcification of the vessel but no occlusion and slight tortuosity of the common femoral artery (cfa).During deployment of a 7.0 x 150 mm biomimics 3d stent (bm3d), there was notable resistance felt during deployment and after about half of the stent was deployed, the device was pulled back and the stent fractured during removal of the delivery system.It was reported that there was elongation of the outer braid and the bifurcated hub had reached the proximal pin luer while a portion of the stent was deployed.The physician removed the device without difficulty and prepared the vessel with additional ballooning.An additional bm3d stent was placed over the fractured portion of stent that remained in the vessel.There were no difficulties with the second bm3d stent deployment.There was no impact to the patient.The vessel was 100% patent.

Manufacturer Narrative

This is related to user facility report number: (b)(4).A review of the lot history records for the relevant stent and delivery system lot showed no issues that were related to this complaint.The bm3d device was not returned for evaluation.It was known that the outer braid became elongated during the procedure.Outer braid elongation suggests that a significantly high deployment force was present.An increased deployment force was experienced following release of a segment of the stent.The physician continued to deploy the stent which resulted in approximately 37 mm of the stent being deployed.The physician removed the bm3d delivery system and access sheath and as a result the stent was stretched and the partially deployed portion fractured and separated.A clinically relevant fracture of this type can occur on removal of the delivery system where the stent has partially deployed.It can result in a prolonged procedure.Veryan is aware that difficult anatomical conditions, including calcification present in the vasculature, tight aortic bifurcations, as well as the presence of vessel tortuosity, can create increased friction between the delivery system components, and between the delivery system and guide/introducer sheath during the stent deployment.This friction can cause increased deployment forces, like what was seen in this complaint, in turn causing delivery system damage.A partial deployment can occur if the user encounters an increased deployment force and continues with the deployment.The patient vessel anatomy was reported as having a mildly calcified sfa, and the cfa was slightly tortuous.The aortic bifurcation angle was tight.These anatomical factors were most likely the root cause of the resistance noted during deployment which led to the partial deployment.The angiographic images of the procedure were not provided and so the vessel anatomy and its condition cannot be fully established.A 7 fr access sheath was used with the device in this procedure.The bm3d is only indicated for use with a 6 fr access sheath as per the ifu.However the investigation concluded that it was unlikely that the use of a 7 fr access sheath contributed to the complaint.The complaint was categorised as a "partial deployment".A cause category of anatomy was assigned in this case.The reported complaint was not related to a deficiency of the device.

Event Description

This is related to user facility report number: (b)(4).On (b)(6) 2023, a physician attempted to treat a 240 mm lesion in the distal superficial femoral artery (sfa) using a 7.0 x 150 mm biomimics 3d stent (bm3d).The patient's vessel had mild calcification in the sfa and the common femoral artery (cfa) was reported as slightly tortuous.The aortic bifurcation angle was tight.The physician used a contralateral approach with a 7 fr access sheath and a 0.035" guidewire.The physician had slight difficulty in crossing the aortic bifurcation with the access sheath due to its tight angle.The physician managed to get the access sheath in place.Prior to the bm3d stent implantation, the target vessel was treated using shockwave intravascular lithotripsy (ivl).The bm3d device was flushed in accordance with the instructions for use (ifu) and introduced into the patient's vessel.It was noted that the physician did not experience any complications crossing the aortic bifurcation with the bm3d device.At this point in the procedure slack was removed from the device and the deployment of the stent was initiated while the proximal pin luer was held in a fixed position.A small portion of the stent released from the outer braid, but the physician then experienced an increased deployment force.The deployment was continued until the bifurcation hub reached the proximal luer pin without full release of the deployed stent from the outer braid.This implied that outer braid elongation had occurred.It was clarified that one quarter of the stent's length (approximately 37 mm) was deployed.The physician decided to remove the bm3d delivery system and access sheath which resulted in fracture and separation of the partially deployed portion of the stent.This portion remained in the patient's vessel.Two additional 7.0 x 150 mm bm3d stents were used to treat the 240 mm target lesion.There were no issues reported with these devices.The partially deployed portion of stent was successfully expanded to oppose the vessel wall.The outcome was reported that the vessel was 100% patent and there were no adverse effects experienced by the patient as a result of the events.

• 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: 17683775
• MDR Text Key: 322647703
• Report Number: 3011632150-2023-00112
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850527
• UDI-Public: (01)05391526850527(17)240803(11)230103(10)0000190061
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• 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: 0000190061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2023
• 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