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

Catalog Number 144700-19

Device Problems Material Separation (1562); Stretched (1601); Detachment of Device or Device Component (2907); Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 09/27/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is in progress.Any additional information received will be provided in a mdr supplemental report.

Event Description

On the (b)(6) 2023, a physician was using a biomimics 3d (bm3d) 7.0 x 150 mm device.When the physician tried to engage the stent, they reported that the rubber part/handle of the device disengaged and separated from the stent.This caused the physician to lose placement of the stent.The physician used a forceps to clamp the stent sheath and force it out of the surgery site.There was no impact to the patient.

Event Description

On the (b)(6) 2023, a physician was attempting to treat the superficial femoral artery (sfa) with a biomimics 3d (bm3d) 7.0 x 150 mm device via a pedal approach.The patient's vessel anatomy had mild tortuosity in the anterior tibial artery and mild calcification in the target lesion.A merit medical 5/6 fr slender access sheath was used.A 0.035" glidewire advantage guidewire was used also.Before stent implantation, the vessel was prepared with percutaneous transluminal angioplasty (pta) balloon and laser atherectomy.The device was flushed in accordance with the ifu and then introduced into the patient.The slack was removed from the delivery system and deployment of the stent was initiated while keeping the proximal pin luer in a fixed position.The physician experienced resistance immediately upon initiating deployment and before the release of any stent crowns from the outer braid.The physician continued to deploy the stent and managed to deploy approximately 50% of the stent's length.The continued deployment resulted in the failure of the outer braid to bifurcation hub bond before the stent had been completely deployed culminating in a partial deployment.At this point, the stent could no longer be deployed from the delivery system.The physician then used a forceps to grip the outer braid and manoeuvre the device in such a way as to release the bm3d stent.The stent was released successfully but was elongated as a result.The delivery system was removed without any issue.The outcome of the procedure was that the target vessel had been revascularized.However, it was noted that there was sub-optimal lumen diameter gain as a result of the stent elongation that occurred.There were no adverse effects to the patient as a result of these issues.

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 not returned for evaluation.There were two images provided to the investigation: an image of the device carton, and an image of the complaint device.A single image of the bm3d device used in this case was displayed in the first image.The complaint device can be seen following its use in the procedure and after its removal from the patient.A separation of the bifurcation hub to the outer braid bond can be seen.The initially reported information in this case noted that the bifurcation hub disengaged, which would suggest that a failure of the bifurcation hub to outer braid bond had occurred.The complaint information received confirmed that a bond failure had occurred.When bond failure is seen, this suggests that a significantly high deployment force was present.It was noted in this case that resistance was experienced upon initiation of deployment and that an increase in resistance occurred when the physician continued the deployment attempt.The ifu provides the following information "warning: 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.".Veryan is aware of the potential for a partial deployment when the user encounters increased force during deployment and continues to deploy the stent.In this case, the physician elected to continue the deployment attempt despite the noted resistance.Veryan is aware that difficult anatomical conditions, including calcification, as well as tortuosity in the access approach vessel, can create increased friction between the delivery system components, and between the delivery system and guide/introducer sheath during the stent deployment.In this case, there was mild calcification of the target lesion and mild tortuosity of the anterior tibial artery reported.The friction created can cause increased deployment forces and in turn, lead to delivery system damage.Angiographic images of the procedure were not provided and therefore the exact anatomical conditions of the vessel cannot be established.The reported conditions of the patient's vessel anatomy are the potential root cause of the resistance noted during deployment, which in turn resulted in delivery system damage and partial deployment.The use of forceps to release the partially deployed stent is contrary to the ifu and is the likely root cause of the stent elongation.It is important to note that the investigation is aware that following the partial deployment, the physician was no longer in a position to deploy the device as per procedure.Deployment of the bm3d in a manner contrary to the instructions can lead to deployment issues.The investigation was categorised as "partial deployment and stent elongation" with cause categories of "user" and "anatomy" assigned.The reported 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: 18021066
• MDR Text Key: 326722954
• Report Number: 3011632150-2023-00130
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850527
• UDI-Public: (01)05391526850527(17)240614(11)221114(10)0000183306
• 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: 01/16/2024

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 Catalogue Number: 144700-19
• Device Lot Number: 0000183306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2023
• Initial Date FDA Received: 10/27/2023
• Supplement Dates Manufacturer Received: 12/18/2023
• Supplement Dates FDA Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2022
• 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