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

Model Number 144700-12

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 01/18/2023

Event Type  malfunction  

Event Description

This is related to mdr number 3011632150-2023-00026.On 18-jan-2023, a veryan representative was made aware of details of a procedure that involved four biomimics 3d (bm3d) devices.The vessel anatomy was reported as tortuous with a tight aortic bifurcation.The vessel was heavily calcified.The first device a bm3d 5.0 x 150mm stent was implanted using a contralateral approach.Following partial deployment of the stent, 1cm broke off during the attempted removal of the device.The 1cm portion which had deployed was fully expanded.The second stent deployed was a bm3d 5.0 x 150mm stent and was implanted in the same anatomical location where the first stent implantation was attempted but a tibial/pedal approach was used and this stent was deployed successfully.The third stent a bm3d 6.0 x 150mm stent (the subject of this report) was implanted using a contralateral approach and was reported as difficult to deploy.The fourth and last stent, a bm3d 6.0 x 125mm stent was successfully deployed using a contralateral approach.There were was no reported impact to the patient.

Manufacturer Narrative

This is related to mdr number 3011632150-2023-00026.The complaint investigation is in progress.Any additional information that becomes available will be provided in a supplemental report.

Manufacturer Narrative

This report is related to mdr number 3011632150-2023-00026.A detailed review of all the lot history records pertaining to the relevant stent and delivery system lots for both complaint devices showed no issues that were deemed related to the complaint investigation.A review of the received images was conducted.These were not the procedural angiographic images but were taken via smartphone.The actual angiographic images were not made available.The images showed calcification of the vessel which reflected the information provided from the physician.The images of the vessel post deployment of the stents showed the separated crowns of the complaint stent which broke on removal of the delivery system.The lots for both devices passed the in-process testing.The reported information described how the bifurcation hub reached the proximal pin luer before all the stent from the first device had deployed leading to the partial deployment.This usually occurs in cases where increased deployment force is present leading to outer braid elongation.The stent fracture also noted in this case occurred as a result of the partial deployment, specifically the removal of the delivery system while approximately one centimetre (1cm) of the stent was released from the outer braid.Difficult anatomical conditions of the vessel (e.G., calcification, vessel tortuosity, and tight aortic bifurcation angles) can create friction between the delivery system, accessory devices and the vessel which can lead to increased deployment forces as seen in this instance.The instructions for use (ifu) states that if there is unexpected resistance at the start of the deployment, the device should be removed carefully without deploying the stent.The information reported included details that the vessel anatomy was tortuous, severely calcified and included a tight aortic bifurcation.There was no vessel preparation conducted prior to advancement of the bm3d device to its target site.The ifu recommends pre-dilation of the lesion using percutaneous transluminal angioplasty (pta) techniques before stenting.Vessel preparation was performed following the partial deployment, which resulted in the successful deployment of three subsequent bm3d stents.This supports the conclusion that inadequate vessel preparation contributed to the increased deployment force noted during the deployment of the first device.In this case the target site extended into the p3 popliteal segment which is below the cortical margin of the femur and is outside the indications for use as per the ifu.The complaint investigation was categorised as a "partial deployment" for the 5.0 x 150mm stent and "difficult to deploy" for the third 6.0 x 150mm stent (the subject of this report).The cause categories assigned were "anatomy, disease/disease progression and user".The complaint was not related to a deficiency of the device.

Event Description

This is related to mdr number 3011632150-2023-00026.On the 18-jan-2023, a veryan representative was made aware of details of a procedure that involved four biomimics 3d (bm3d) devices.The vessel anatomy was reported as tortuous with a tight aortic bifurcation.The vessel was heavily calcified.There was no vessel preparation conducted prior to insertion and advancement of the first device.The first device a bm3d 5.0 x 150mm stent was implanted using a contralateral approach to treat the distal superficial femoral artery (sfa) to p3 segment of the popliteal artery in the right leg.The physician experienced resistance when crossing the target lesion due to the presence of calcium in the vessel.It was noted that vessel calcification was creating friction with the bm3d device.Once the physician had positioned the device, they began the deployment and immediately reported resistance.The physician continued with the deployment.One centimetre (1 cm) of the stent was released before the bifurcated luer hub reached the proximal pin luer and no more of the stent could be deployed.Following partial deployment of the stent, 1cm broke off during the attempted removal of the device.The 1cm portion which had deployed was fully expanded.The physician prepared the target site with balloon angioplasty before implanting the next stent.The second stent deployed was a bm3d 5.0 x 150mm stent and was implanted in the same anatomical location where the first stent implantation was attempted but a tibial/pedal approach was used and this stent was deployed successfully.The third stent a bm3d 6.0 x 150mm stent (the subject of this report) was implanted using a contralateral approach and was reported as difficult to deploy.The fourth and last stent, a bm3d 6.0 x 125mm stent was successfully deployed using a contralateral approach.There was no reported impact to the patient.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Type of Device: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL LTD.; unit 11 galway technology park; parkmore road; galway, H91VE 0H; EI H91VE0H
• Manufacturer Contact: alan mcdonagh ; unit 11 galway technology park; parkmore road; galway, H91VE-0H ; EI H91VE0H
• MDR Report Key: 16377579
• MDR Text Key: 309561145
• Report Number: 3011632150-2023-00027
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850510
• UDI-Public: (01)05391526850510(17)240506(11)221006(10)0000176703
• 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: 04/06/2023

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: 05/06/2024
• Device Model Number: 144700-12
• Device Catalogue Number: 144700-12
• Device Lot Number: 0000176703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 03/08/2023
• Supplement Dates FDA Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2022
• 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