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

Model Number	144700-19
Medical Device Problem Codes	Fracture (1260); Stretched (1601); Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907); Activation Failure (3270); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation associated with this complaint is currently in progress.Any additional information that becomes available will be provided in a mdr supplemental report.
Event or Problem Description
On the (b)(6) 2023, during usage of a biomimics 3d (bm3d) 7.0 x 150mm vascular stent system the site reported that it seemed stiff going up and over.The physician pulled back and the delivery system appeared to disconnect and the stent began to flower.The physician pulled out the device and the flowered stent got caught on a sheath in the access leg.The physician had to cut the sheath and pulled everything out.There was no impact to the patient reported.
Additional 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 device was returned and evaluated.The device was returned without the stent present in the delivery system and the bifurcation hub was fully retracted to the proximal pin luer.The delivery system possessed a cast and it was prone to curl up.The distal guidewire lumen was severely damaged and was segmented into separate parts and showed elongation.The distal tip was absent.The 0.014" guidewire used with the device was still present in the guidewire lumen.The damage to the guidewire lumen was examined under the microscope.There were multiple points of damage along the portion of the guidewire that was visible distally to the outer braid.There were points of elongation, separation and kinking.The inner shaft of the device could not be retracted from the proximal pin luer due to the friction experienced.The outer braid was elongated which suggested the device was subjected to a significant tensile force during use.The proximal pin luer to hypotube bond and the support shaft to inner shaft bond were intact.The distal tip to peek bond and the outer braid to bifurcation hub bond were separated.The presence of sanding marks on the outer braid and the presence of glue in the blue bifurcating luer port indicated that the manufacturing steps were performed as intended.The distal outer braid and its radiopaque marker were free from damage.The bond failure and braid elongation that were observed suggested that a significantly high deployment force was present.It was noted in this case that resistance was experienced upon initiation of deployment.The physician continued their attempt to deploy the stent, which resulted in roughly 1cm of the stent being deployed.The ifu states "if unexpected resistance is felt at the start of the deployment, do not force the movement of the bifurcation luer; instead, carefully withdraw the sds without deploying the stent." there is the potential for a partial deployment when the user encounters increased force during deployment and continues to deploy the stent.Veryan is aware that difficult anatomical conditions, including calcification and/or occlusion present in the vasculature, 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, in turn causing delivery system damage as was observed with this complaint.Therefore, the presence of calcification in the target site was the most likely cause of the resistance noted during deployment, which in turn resulted in the partial deployment.The anatomical conditions of the patient's vessel present in this complaint cannot be fully established as no procedural angiographic imaging was provided.There was difficulty removing the device as 1 cm of the stent was released from the outer braid, the outer diameter of the complaint device would have been larger than the specification diameter for the outside catheter.This would result in unanticipated friction between the delivery system and the inner surface of the access sheath, as was reported in this case.The access sheath had to be cut by the physician in order to remove the device.This resulted in damage of the distal guidewire noted during the investigation of the device.The physician elected to use a 0.014" guidewire with the biomimics 3d device.The biomimics 3d device is indicated for use with a 0.035" guidewire size.The complaint was categorised as a "partial deployment" with a cause category of "user" assigned.The complaint was not related to a deficiency of the device.
Event or Problem Description
On (b)(6) 2023, a physician attempted to treat the mid and distal superficial femoral artery (sfa) of a patient using a 7.0 x 150mm biomimics 3d (bm3d) stent.The patient anatomy had diffuse disease and mild to moderate calcification in the sfa.A contralateral approach was used and a 6fr cook flexor 55 cm access sheath was used with a 0.035" glidewire and a 0.014" viper guidewires.The vessel was prepared using laser atherectomy with a cardiovascular systems inc (csi) diamondback device.The bm3d device was flushed in accordance with the instructions for use (ifu).There were no issues reported when crossing the aortic bifurcation.The slack was removed from the device and the deployment of the device was initiated while holding the proximal pin luer hub in a fixed position.However, resistance was experienced immediately upon initiation of deployment prior to the release of any stent crowns from the outer braid.The physician continued the deployment attempt and released 1cm of the stent.The released stent did not oppose the vessel wall.The physician felt a snap in the delivery system at this point in the deployment.The stent could no longer be deployed and the delivery system was removed.Difficulty was experienced withdrawing the device as the flowered stent could not be retracted through the access sheath and it became stuck.As a result, the distal tip detached from the system but remained in the guidewire.The physician cut the access sheath to remove the bm3d device.While cutting the access sheath, the revealed stent crowns fractured.The physician successfully removed the delivery system and no ancillary devices were required to remove the device.The detached distal tip was also removed and no stent crowns were left in the patient anatomy.A competitor device was used to finalise the procedure and was successfully deployed.No additional vessel preparation was performed between removal of the bm3d device and use of the competitor device.No adverse effects to the patient were reported as a result of the procedure.It was stated that a favourable patient outcome was achieved.

• Brand Name: BIOMIMCS 3D VASCULAR STENT SYSTEM
• Common Device Name: BIOMIMCS 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: 17098143
• Report Number: 3011632150-2023-00069
• Device Sequence Number: 1983177
• Product Code: NIP
• UDI-Device Identifier: 05391526850527
• UDI-Public: (01)05391526850527(17)240803(11)230103(10)0000190061
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P180003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/03/2024
• Device Model Number: 144700-19
• Device Catalogue Number: 144700-19
• Device Lot Number: 0000190061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown