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

Model Number 142122-10

Device Problems Fracture (1260); Stretched (1601); Difficult or Delayed Activation (2577); Difficult to Advance (2920)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/09/2022

Event Type  malfunction  

Event Description

On the (b)(6) 2022 during an implantation of a biomimics 3d device where the physician used a pedal access over a 6/5 terumo glidesheath slender over a mongo wire, the biomimics stent elongated.The physician confirmed they pin and pulled and the manager confirmed the pin did not move.The patient must return for additional follow-up.The physician believes that the stent elongation is related to the device.

Manufacturer Narrative

The complaint investigation is in progress.If any additional information becomes available a supplemental report will be submitted.

Manufacturer Narrative

The lot number was not provided so no device history record could be obtained.Additional information provided by the physician on the procedure was as follows: the target site was the mid to distal sfa and a pedal approach was used via the anterior tibial (at) and tibioperoneal trunk (tpt) arteries.A 0.014" mongo wire was used and an occlusion was present above a biomimics 3d stent which was placed sometime before.The device was flushed according to the ifu and there was resistance felt during advancement of the delivery system through the tight turn at the origin of the at.There was difficulty during deployment when retracting the bifurcation hub to the luer pin.The stent ultimately deployed elongated.A week later the patient was brought back for review and imaging highlighted that the elongated stent had fractured at mutiple locations.The vessel was patent so no further treatment was conducted and the physician will monitor the patient.The imaging provided via smarthone for the investigation was not the original angiographic imaging and while stent fractures are evident, the deployed position of the elongated stent and the extent of elongation cannot be confirmed.Calcification of the mid sfa is also evident.It cannot be confirmed from the imaging if the portion of the elongated stent deployed within the bm3d stent that already existed below the lesion which was being treated.It is possible that the challenging anatomical conditions of the vessel contributed to high deployment forces which led to stent distortion although this cannot be confirmed.The category of this complaint assigned was "difficult to deploy, stent elongation and stent fracture type ii to type v".The root cause cannot be confirmed and is unknown.Section b.5.And section h.6.Have been updated to align with the conclusion of the investigation.If any additional information becomes available it will provided in a follow-up supplemental report.

Event Description

On the 09-may-2022 during an implantation of a biomimics 3d (bm3d) 6 x 100mm device to treat a lesion in the mid to distal sfa located above an already implanted bm3d device ( 6 x 100mm stent, which had been implanted some months earlier), the physician used a pedal access over a 6/5 terumo glidesheath slender over a mongo wire, and the biomimics stent being used to treat the lesion elongated as it was being deployed.A portion of the stent was deployed within the already implanted stent.The physician confirmed they pin and pulled and the manager confirmed the pin did not move duing depoyment.The patient must return for additional follow-up.The physician believes that the stent elongation is related to the device but also the tight turn at the anterior tibial artery may have been a factor.

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.The device was returned for evaluation.It was returned with the access sheath (a 6fr terumo glidesheath) still in place at the strain relief of the delivery system.This was removed from the device to enable the device evaluation.A note worthy length of the inner shaft was observed protruding from the proximal end of the bifurcation hub.The device tip was not visible and the guidewire lumen could not be determined.The device was congested with congealed blood.Following microscopic examination of the distal end of the delivery system a tear was noted on the outer braid and radiopaque marker band.The outer braid was retracted along the inner shaft to align the shafts as intended.There was a lot of resistance while retracting the outer braid.The movement caused a significant amount of congealed blood to be expelled from the distal end of the delivery system.There was a high level of friction reported between the two device shafts.The resistance led to separation of the outer braid to bifurcation hub bond.Further retraction led to alignment of the delivery system shafts as intended.There was a slight cast observed in the device and the distal tip and guidewire lumen were still not visible.Upon removal of the inner shaft from the proximal end of the outer braid, it was identified that the guidewire lumen and distal tip were still present on the inner shaft.No issues were identified following visual inspection of the components.It was concluded that based on the condition of the returned device, the inner shaft had been retracted through the outer braid to an extent that the distal tip of the device was confined within the outer braid.The tear on the distal end of the delivery system was most likely as a result of the extent of retraction of the inner shaft through the outer braid.The distal tip has a greater outer diameter than the inner diameter of the outer braid and the movement of the parts of the delivery system would have placed unintended force on the radiopaque marker band and distal outer braid.The presence of the distal tip within the outer braid and the level of congealed blood within the delivery system explains the friction noted during the retraction process.The stent was no longer present in the delivery system which confirms the reported information that the stent had been deployed.The root cause of the stent fracture could not be confirmed.It was noted by the physician that there was resistance as the device was being advanced through the anterior tibial artery and the tibio-peroneal trunk to the target site, which is an indication of difficult anatomical conditions.These anatomical conditions may have caused the high deployment force, which likely caused the stent distortion, which in turn, could have resulted in the stent fracture.The root cause remains unchanged and is still determined as "unknown".The complaint category remains as "difficult to deploy, stent elongation, stent fracture type ii-v".Sections b.5., d.4., d.9., h.4., h.6., have been updated to reflect the additional information received.

Event Description

On the 09-may-2022 during an implantation of a biomimics 3d (bm3d) 6 x 100mm device to treat a lesion in the mid to distal sfa located above an already implanted bm3d device ( 6 x 100mm stent, which had been implanted some months earlier), the physician used a pedal access over a 6/5 terumo glidesheath slender over a mongo wire, and the biomimics stent being used to treat the lesion elongated as it was being deployed.A portion of the stent was deployed within the already implanted stent.The physician confirmed they pin and pulled and the manager confirmed the pin did not move during depoyment.The physician believes that the stent elongation is related to the device but also the tight turn at the anterior tibial artery may have been a factor.A week after the implantation procedure, angiography revealed the elongated stent had fractured.

• 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: 14564687
• MDR Text Key: 300811045
• Report Number: 3011632150-2022-00034
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850459
• UDI-Public: (01)05391526850459(17)221223(11)210524(10)0000088892
• 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,Followup
• Report Date: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/23/2022
• Device Model Number: 142122-10
• Device Catalogue Number: 142122-10
• Device Lot Number: 0000088892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2021
• 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