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

Catalog Number 142122-14

Device Problems Fracture (1260); Material Deformation (2976)

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

Event Date 08/08/2023

Event Type  malfunction  

Event Description

The patient was treated with two 6.0 x 150 mm biomimics 3d (bm3d) stents on (b)(6) 2023 in the proximal and distal superficial femoral artery (sfa).The patient then developed an acute occlusion on (b)(6) 2023 and was administered thrombolytics overnight and returned to lab on (b)(6) 2023.It was decided to treat the unstented segment due to that area being severely dissected.A 6.0 x 125 mm bm3d stent fractured upon deployment in the left mid sfa.The fractured stent was covered with a viabahn stent followed by thrombectomy.Blood flow was re-established with 2 vessel runoff.There was no reported impact to the patient.

Manufacturer Narrative

The investigation is in progress and any additional information will be provided in a mdr supplemental report.

Event Description

On (b)(6) 2023, a physician attempted to treat the mid superficial femoral artery (sfa) of a patient's left leg with a 6.0 x 125 mm bm3d device.The patient anatomy was noted as having an occlusion and calcification of the entire sfa.The access to the target site was achieved using a terumo access sheath and 0.018" command guidewire.The physician prepared the target location via balloon angioplasty and laser atherectomy.The bm3d device was flushed in accordance with instruction for use (ifu).The device was introduced into the patient.The device was advanced to the target site.At this point, slack was removed from the system and deployment of the stent was initiated while holding the proximal pin luer in a fixed position.The deployment attempt resulted in the successful deployment of the bm3d stent, and feedback was provided that no issues were experienced.It was reported that there was no elongation of the outer braid during the deployment.Following completion of the deployment of the bm3d stent, the physician removed the delivery system.The physician then performed post-dilation where the balloon was inflated at 11 atmospheres (atm) for 30 seconds.The balloon was then removed and described as intact.It was at this point of the procedure that a potential stent fracture was identified by the physician.It was reported that a type 2 fracture had occurred, indicating multiple single strut fractures.The physician carried out additional vessel preparation and competitor stents were deployed at the target site.No issues were reported with the deployment of the additional stents.It was reported that the patient's outcome was good, and that no adverse events had occurred as a result of the events of this complaint.

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.Two smartphone images of the bm3d stent were provided for investigation.The original angiographic images were requested by veryan but these were not made available by the complaint site.Angiographic images are crucial in an investigation in determining the condition of the bm3d stent, as a thorough angiographic review will include multiple angle images of the implanted stent.The smartphone images provided did not display full separation of stent crowns but did show a downward distortion of multiple stent struts.This downward distortion was potentially the result of a type 2 stent fracture, but this could not be fully determined.A stent fracture could not be confirmed.It was understood that the bm3d device was deployed successfully without issue.After deployment, the physician elected to post-dilate the bm3d stent.It was after this balloon dilation the reported stent fracture was identified.Veryan is aware that the potential for stent distortion exists when the user moves a post-dilation balloon while it is at full expansion.However, in this case the root cause cannot be established without the angiographic images to enable determination of the condition of the stent.The complaint was categorised as a distorted stent pattern.The cause could not be established due to insufficient information.It could not be established if the complaint was related to a deficiency of the device.Sections b.5., d.6.A., g.6., h.6.And h.10.Have been updated.

• 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: 17688750
• MDR Text Key: 322707794
• Report Number: 3011632150-2023-00115
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850480
• UDI-Public: (01)05391526850480(17)231113(11)220414(10)0000145156
• 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: 10/27/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2023
• Device Catalogue Number: 142122-14
• Device Lot Number: 0000145156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2023
• Initial Date FDA Received: 09/06/2023
• Supplement Dates Manufacturer Received: 09/29/2023
• Supplement Dates FDA Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2022
• 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