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

Catalog Number 142122-15

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

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

Event Date 01/27/2024

Event Type  malfunction  

Event Description

On 27-jan-24, one 7.0 x 125 mm biomimics 3d stent (bm3d) was used in a procedure to treat the mid-popliteal artery in the right leg.The bm3d is only indicated for use in the superficial femoral artery (sfa) to the proximal popliteal artery.A contralateral approach was used and the vessel was prepared using a 1.5mm auryon laser atherectomy and a 4.0 mm and 7.0 mm balloon angioplasty.A 6 fr biotronik 45 cm crossover access sheath was used with a boston zipwire 0.035" x 180 cm guidewire.There was a 65% mid-popliteal artery occlusion.There was no vessel calcification or tight aortic bifurcation angle.There was no tortuosity of the vessels reported.There were no issues crossing the aortic bifurcation.At the initiation of the deployment notable resistance was felt.The delivery system was flushed in accordance with the instructions for use (ifu), the tuohy burst valve was opened prior to deployment and the pin luer was held in a fixed position during the deployment process.Any excess slack was removed from the delivery system during deployment.No part of the stent was revealed during the deployment.There was no bond failure or elongation of the outer braid reported.The entire delivery system was removed as soon as the physician found that the delivery system was fractured.There was no difficulty removing the delivery system.A competitor stent was used to finish the procedure.There was no additional vessel preparation used prior to this deployment and there were no issues with this deployment.There was no residual popliteal artery stenosis and the physician reported excellent in-line flow to the foot.The sheath and guidewire were removed and hemostasis was achieved with a 6f celt device.The patient was discharged with dressing and there were no complications.

Manufacturer Narrative

The investigation is in progress and any additional information that becomes available will be reported in a follow-up report.

Manufacturer Narrative

The device history record (dhr) review showed no issues that were related to this complaint.The device was returned and evaluated.It was found that the outer braid to the bifurcation hub bond had separated.There was a severe cast in the delivery system as well as inner shaft damage at a point just proximal to the part of the delivery system where the severe cast was observed.The outer braid was also found to be elongated.The outer braid to bifurcation hub bond was examined via microscope and it was determined that it had been manufactured as intended as there was the presence of sanding marks on the outer braid and glue residue.The bond separation identified was understood to be the delivery system fracture initially reported.The radiopaque marker of the distal outer braid was also damaged.The distal tip was retracted into the confines of the distal outer braid which likely caused the observed damage.An attempt was made to deploy the stent, this resulted in severe friction.There was roughly 10 cm of the stent deployed but it could not be fully deployed due to the increased deployment force.A braid outer diameter reduction had occurred in the region of the inner shaft damage.The friction between both components of the outer braid and inner shaft was likely responsible for the increased deployment force.The continued deployment attempt in the presence of the resistance experienced at the deployment initiation likely led to the elongation of the outer braid and separation of the bond.The resistance experienced occurred prior to the release of any of the stent crowns.As per the instructions for use (ifu), it is recommended that in such cases of resistance at the initiation of the deployment, the device should be carefully withdrawn without deploying the stent.The 65% occlusion present in the vessel at the target site may have contributed to the increased friction between components of the delivery system and between the delivery system and the guide/introducer sheath leading to the resistance experienced.There were no angiographic images provided so the exact conditions of the vessel cannot be established but the severe cast and inner shaft damage observed are suggestive of difficult diseased vessel conditions.The complaint was categorised as an unable to deploy event with a cause category of disease/disease progression assigned.The complaint event was not related to a deficiency of the device.Section b.5.Was updated, sections g.6.And h.2.Were updated to reflect the report type (follow-up 01) and reason, section h.6.Was updated to align with investigation conclusions and section h.11.Was updated to reflect the sections changed in this report.

Event Description

On (b)(6) 2024, one 7.0 x 125 mm biomimics 3d stent (bm3d) was used in a procedure to treat the mid-popliteal artery in the right leg.The bm3d is only indicated for use in the superficial femoral artery (sfa) to the proximal popliteal artery.A contralateral approach was used and the vessel was prepared using a 1.5mm auryon laser atherectomy and a 4.0 mm and 7.0 mm balloon angioplasty.A 6 fr biotronik 45 cm crossover access sheath was used with a boston zipwire 0.035" x 180 cm guidewire.There was a 65% mid-popliteal artery occlusion.There was no vessel calcification or tight aortic bifurcation angle.There was no tortuosity of the vessels reported.There were no issues crossing the aortic bifurcation.At the initiation of the deployment notable resistance was felt.The delivery system was flushed in accordance with the instructions for use (ifu), the tuohy burst valve was opened prior to deployment and the pin luer was held in a fixed position during the deployment process.Any excess slack was removed from the delivery system during deployment.No part of the stent was revealed during the deployment.There was no bond failure or elongation of the outer braid reported.The entire delivery system was removed as soon as the physician found that the delivery system was fractured.There was no difficulty removing the delivery system.A competitor stent was used to finish the procedure.There was no additional vessel preparation used prior to this deployment and there were no issues with this deployment.There was no residual popliteal artery stenosis and the physician reported excellent in-line flow to the foot.The sheath and guidewire were removed and hemostasis was achieved with a 6f celt device.The patient was discharged with dressing and there were no complications.There was no adverse effect on the patient.There was a prolonged procedure as a result of the event.The investigation was finalised on 13-mar-24 and determined this event as an unable to deploy event due to the disease/disease progression in the vessel.The complaint was not related to a deficiency of the device.

• 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: 18786836
• MDR Text Key: 337531672
• Report Number: 3011632150-2024-00005
• Device Sequence Number: 1
• Product Code: NIP
• 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: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 142122-15
• Device Lot Number: 0000265044
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2023
• 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