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

Model Number 144700-19

Device Problems Break (1069); Activation Failure (3270); Physical Resistance/Sticking (4012)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/08/2022

Event Type  Injury  

Event Description

This mdr report is related to the voluntary report submitted on 20-jun-22 reference mw5110473.Both reports provide detail in relation to the same event that occurred.On (b)(6) 2022, a physician was treating a patient with a chronic total occlusion (cto) of the right superficial femoral artery (sfa).The physician was able to recanalise the vessel using a contralateral and pedal approach.The target lesion was treated with numerous percutaneous balloon angioplasty (pta) dilations and shockwave lithotripsy.A biomimics 3d (bm3d) 6 x 100mm stent was successfully deployed in the middle to distal sfa using a contralateral approach through a 6fr x 45cm sheath and a 0.035" terumo glide advantage guidewire.The vessel anatomy was not reported as tortuous.There was no resistance felt during advancement to the target site.There was slight resistance felt during deployment initiation which caused the device to move proximal to the 6x 100mm stent the physician is reported to have inadvertently partially deployed a short segment of the 7 x 150mm stent several millimetres above the 6 x 100mm stent.The physician then decided to withdraw the 7 x 150 mm stent and use another one.A portion of the stent broke off during withdrawal and remained in the right proximal sfa.Upon attempting to deliver the second 7x150mm stent it was discovered on angiographic imaging that approximately 10mm had separated from the tip of the sheath.The sheath was exchanged.The physician does not consider the incident related to the device and does not blame the device for the event.He was advised that the sheath would not accommodate the partially deployed stent.The sheath was advanced through the portion of stent that remained in the vessel and another 7 x 150mm stent was delivered successfully.The bm3d 7 x 150mm stent was overlapped with the 6 x 100 mm stent to treat the middle to proximal sfa.The post procedural angiographic imaging revealed brisk bloodflow through the entire sfa/popliteal arteries and there were no complications reported.

Manufacturer Narrative

This mdr report is related to the voluntary report submitted on 20-jun-22 reference mw5110473.Both reports provide detail in relation to the same event that occurred.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 complaint investigation is still in progress and any additional information received will be submitted as a supplemental follow-up report.

Manufacturer Narrative

A detailed review of all the lot history records pertaining to the relevant stent and delivery system lots showed no issues that were deemed related to the complaint investigation.A list of questions were sent to the site involved and the response received confirmed the following: a contralateral approach was used and there were no issues crossing the aortic bifurcation and there was no tortuosity in the iliacs.The vessel was prepared with shockwave lithotripsy and pta balloons.A 6fr sheath was used with a 0.035" guidewire.The initially placed 6 x 100mm biomimics 3d stent deployed successfully in the mid to distal sfa.Then the 7 x 150mm stent was introduced.There was no resistance during advancement to the target site.The pin luer was held in a fixed position during deployment.There was slight resistance during deployment, which led to inadvertent pulling on the entire system and resulted in the device being deployed several millimetres above the intended position.The partially deployed 7 x 150mm delivery system was withdrawn and a second bm3d delivery system was used.It was discovered on angiography that 10mm of the partially deployed stent remained in the vessel.The guide sheath was passed through the separated portion and a second 7 x 150mm bm3d was used and there was also slight resistance reported.The physician does not believe the complaint is related to the device.The evaluation of the returned device identified noteworthy kinks halfway down the braid.This may be due to the nature in which the device was returned.There is also a minor cast on the device.All bonds were intact.The outer braid did not show signs of elongation.There were 5 crowns that were unaccounted for and these are likely the portion that remained in the vessel.The images provided were not the original angiographic images but were taken via smartphone.There is evidence to suggest the sfa was calcified during deployment which could potentially increase the required deployment force during initiation.The slight resistance encountered by the physician led to movement of the device delivery system (ds) more proximal to what was intended.The stent was then partially deployed at a more proximal location to the intended target site.The physician inadvertently deployed the stent above the intended location.Movement of the luer pin during deployment may have led to the events described.The ds was withdrawn in a partially deployed state leading to separation of part of the stent.A second bm3d 7 x 150mm device was deployed successfully and the slight resistance which caused proximal movement of the first device had no impact on the second device.No additional vessel preparation was performed prior to the second 7 x 150mm device implantation.The proximal movement of the complaint device is not thought to be due to the resistance encountered but likely due to the luer pin not being held in a fixed position.The complaint investigation categorises this complaint as a "partial deployment" with the cause category assigned as "user".The calcified sfa may have led to increased deployment force and movement of the delivery system proximal to what was intended.Deployment was then started in the incorrect position and a decision to withdraw the device led to the separation of the partially deployed stent.It is also likely that the device could have been repositioned prior to initiating deployment avoiding the events that followed.Sections h.6.Has been updated as a result of the additional information.This report is being submitted late and the root cause for this late submission is being investigated.

• 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 city, H91 V E0H; EI H91 VE0H
• Manufacturer Contact: alan mcdonagh ; unit 11 galway technology park; parkmore road; galway city, H91 V-E0H ; EI H91 VE0H
• MDR Report Key: 14950840
• MDR Text Key: 295475028
• Report Number: 3011632150-2022-00044
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850527
• UDI-Public: (01)05391526850527(17)231105(11)220406(10)0000131305
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2023
• Device Model Number: 144700-19
• Device Catalogue Number: 144700-19
• Device Lot Number: 0000131305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2022
• 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; Required Intervention