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

Catalog Number 145276-12

Device Problems Stretched (1601); Activation Failure (3270)

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

Event Date 03/15/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 15-mar-23, it was reported that following deployment of a 6.0 x 150mm biomimics 3d (bm3d) stent via a crossover approach using a 6f fortress crossover sluice (45 cm long) and a 0.014" guide-wire, the stent was elongated.The deployment was reported as uneventful with no unusual friction noted.The physician reported that at the beginning of the stent release there was a feeling that nothing was moving and slowly they applied more pressure until the outer sheath started to retract.Once the initial high resistance was overcome, the deployment felt completely normal until the end.The outer sheath had been retracted as far as it would go.The physician suspected that the outer sheath was stretched during the deployment and therefore the stent was not fully released by the time the outer sheath retraction was completed.Following evaluation of the post-deployment imaging, the physician noted elongation of the proximal part of the deployed stent.There was no impact to the patient.

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.A review of the imaging prior to vessel preparation and bm3d implantation identified that the sfa was occluded and moderately calcified.The imaging of the complaint stent following deployment identified that the stent had elongated in the proximal section due to stretching of the proximal eight (8) crowns.Imaging also confirmed the position of the competitor stent used which was overlapped with the elongated section of the bm3d stent.It was known from the information provided that the bifurcation hub of the bm3d delivery system had reached the proximal pin luer before fully releasing the stent.This was considered a partial deployment.This indicated that the outer braid had elongated during deployment which suggested that a high deployment force was present.It was reported that in this case there was resistance at initiation of deployment.The ifu provides the following: "warning: if unexpected resistance is felt prior to deployment, do not force the stent delivery system; instead, carefully withdraw the sds without deploying the stent".The risk management file also documents that a partial deployment is a possible outcome where a physician continues a deployment despite encountering an increased deployment force.Veryan is aware that difficult anatomical conditions, including calcification and/or occlusion present in the vasculature, as well as a tight aortic bifurcation, can create increased friction between the delivery system components, and between the delivery system and guide/introducer sheath during the stent deployment.This friction can lead to increased deployment forces which in turn can cause damage to the delivery system.There was calcification, occlusions and a tight aortic bifurcation angle reported by the physician in this case, which can lead to increased resistance resulting in outer braid elongation and partial deployment of the stent.The physician continued to deploy the device despite experiencing resistance at the initiation of deployment.Continuing the deployment of the bm3d stent despite the increased deployment force likely placed friction upon the delivery system, which has the potential to negatively impact the delivery system.Therefore, the user is the likely root cause of the noted outer braid elongation and partial deployment.Due to the nature of the stent elongation seen in this case, with the proximal 8 crowns of the stent having been stretched proximally (in the direction in which the delivery system was moved), it is believed that the delivery system was retracted prior to the full release of the stent from the outer braid.It is known that the bifurcation hub of the device reached the proximal luer without the full release of the stent during the deployment.At this point, the physician was unable to continue deployment, which subsequently caused the movement of the delivery system prior to the completion of deployment.The investigation concluded that the noted outer braid elongation of the delivery system was responsible for the stent elongation reported.The complaint was categorised as a "stent elongation and partial deployment".The cause categories assigned were "anatomy" and "user".

Event Description

On (b)(6) 2023, a physician attempted to revascularize an occluded superficial femoral artery (sfa) of the left leg with a 6 x 150 mm biomimics 3d (bm3d) device.A contralateral approach was taken, using a.014" guidewire and a 6 fr 45 cm fortress access sheath.The physician prepared the target site with several percutaneous transluminal angioplasty (pta) balloon expansions across a range of sizes, and several drug coated balloon angioplasty expansions across a range of sizes, prior to introduction of the bm3d device.The patient anatomy was described as having calcification in the iliac, femoral and distal sfa, as well as occlusion in the proximal and middle sfa.It was also noted that a tight aortic bifurcation was present.The device was flushed in accordance with the instructions for use (ifu), and then introduced to the patient.No resistance was noted during device advancement.When in position at the target site, the physician removed slack from the delivery system and then initiated deployment while securing the proximal pin luer in a fixed position.Resistance was noted during the initiation of deployment.However, this resistance dissipated once the first stent crown was released from the outer braid.It was noted by the physician that they closely watched the deployment of the distal portion of the bm3d stent, but then did not look to see the deployment of the proximal portion of the stent.The physician then retracted the delivery system to remove it from the patient at the point the bifurcation hub had reached the proximal luer, believing that the stent had been fully deployed.However, the deployment of the stent had not completed.Therefore, the delivery system had been retracted before the full release of the stent.No resistance was noted during removal of the bm3d device.It was at this point that the physician identified that potential stent elongation had occurred, and it was reported that the stent had a length of 170 mm, with elongation of roughly the proximal 6 stent crowns.The bm3d stent was then post-dilated, and a competitor 6 x 200 mm stent was placed proximally to the complaint device, with an overlap in the region of potential stent elongation.This led to a prolonged procedure.No patient issues were noted and there was no patient impact.The device remains implanted.

• Brand Name: BIOMIMICS 3D STENT SYSTEM
• Type of Device: BIOMIMICS 3D STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL LTD; unit 11 galway technology park; parkmore road; galway, H91 V E0H; EI H91 VE0H
• Manufacturer Contact: alan mcdonagh ; unit 11 galway technology park; parkmore road; galway, H91 V-E0H ; EI H91 VE0H
• MDR Report Key: 16733219
• MDR Text Key: 313311339
• Report Number: 3011632150-2023-00052
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850329
• UDI-Public: (01)05391526850329(17)240430(11)220930(10)0000175611
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P180003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 145276-12
• Device Lot Number: 0000175611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2022
• 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