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

Model Number 144700-19

Device Problems Break (1069); Material Separation (1562); Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 06/16/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022 a physician was implanting a biomimics 3d 7 x 150mm stent and during deployment the physician reported resistance was experienced and when the stent emerged, a piece broke off and the physician had to snare and remove it.This led to an extension in the procedure and to finish the case two competitor stents were used as the target lesion was reported as a long lesion.The patient was discharged on the same day without any impact or consequences.The device is returning for evaluation.The complaint investigation is in progress and any new or additional information will be provided in a supplemental/follow-up report.

Manufacturer Narrative

The complaint investigation is in progress and the device is returning for evaluation.Any new or additional information will be provided in a supplemental/follow-up report.

Event Description

On (b)(6) 2022, the physician began to deploy a biomimics 3d (bm3d) 7 x 150mm stent to treat a lesion of the distal superficial femoral artery (sfa).A contralateral approach was used along with a 0.035" guidewire.The lesion was prepared using laser atherectomy and balloon angioplasty.There was nothing abnormal reported in relation to the occlusion, tortuosity of the vessel, or the aortic bifurcation angle.The lesion being treated was described as a long lesion.The device was flushed in accordance with the ifu.No resistance was reported by the physician during device advancement to the target site but there was resistance experienced upon initiation of deployment.Following deployment of 1cm of the stent, the physician was unable to finalise deployment.The physician decided to remove the bm3d device and reported that there was resistance during removal of the device and then the partially deployed stent fractured.The physician reported that he observed the outer braid to bifurcation hub bond had separated, and the outer braid had elongated, while removing the delivery system from the patient.The physician was able to snare the fractured stent crowns and removed them from the patient successfully.Following this, (b)(4) bm3d stent and (b)(4) non bm3d stents were used to treat the long lesion.The patient was discharged on the same day without any impact or consequences.

Manufacturer Narrative

The investigation on this complaint has been finalised.A detailed review of all the lot history records relating to the relevant stent and delivery system lots identified no issues that were deemed related to the complaint investigation.The device was returned for evaluation.Visual inspection noted that fractured stent struts were observed protruding from the distal end of the delivery system.There was no damage to the distal tip or the radiopaque marker band and the distal tip was observed to be fully retracted to the edge of the outer braid.The delivery system had a visible cast and tended to curl up.This is possibly due to the nature of the vessel path, which it had been tracked through during the procedure.The outer braid to bifurcation hub bond separation and outer braid elongation were also observed.Braid elongation and/or separation of the bifurcation hub to outer braid bond is typically caused by increased friction.The steel inner shaft also had a severe bend which is likely due to the way the device was packaged for return.An attempt was made to deploy the stent but it could not be deployed due to presence of congealed blood along the length of the inner shaft.It was reported that during the event, resistance was noticed during initiation of deployment, but the physician continued to deploy the stent.The ifu states that "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.'.Partial deployment is a possibility in cases where outer braid to bifurcation hub bond separation occurs and/or outer braid elongation occurs in cases which exhibit high deployment forces.The lot related to this device passed its in process monitoring and testing and the deployment forces met the specification limits.The sequence of this case's events highlights that the resistance at initiation, and subsequent separation of the outer braid to bifurcation hub that occurred during deployment likely led to the partially deployed stent and that deployment could not be continued.The removal of the delivery system likely led to the partially deployed stent fracturing.The root cause was not confirmed but increased friction to the device and its components can be caused by various factors which can include tortuous vessel anatomy, inadequate lesion preparation and steep angles at the aortic bifurcation and introducer sheath.However, the exact conditions of the vasculature and target lesion cannot be confirmed without the angiographic imaging, which was not provided to the investigation team for review.The complaint was categorised as a "partial deployment" and the cause category assigned was "unknown".Sections b.5., d.9., 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; 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: 15005182
• MDR Text Key: 304604126
• Report Number: 3011632150-2022-00051
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850527
• UDI-Public: (01)05391526850527(17)230922(11)210222(10)0000135822
• 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: 10/28/2022

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: 09/22/2023
• Device Model Number: 144700-19
• Device Catalogue Number: 144700-19
• Device Lot Number: 0000135822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2022
• Initial Date FDA Received: 07/13/2022
• Supplement Dates Manufacturer Received: 10/06/2022
• Supplement Dates FDA Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2022
• 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