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

Catalog Number 145276-05

Device Problems Fracture (1260); Material Separation (1562); Stretched (1601); Activation Failure (3270); Physical Resistance/Sticking (4012)

Patient Problems Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is in progress.The device is being returned to veryan.Any additional information that becomes available will be provided in a follow-up supplemental report.

Event Description

On (b)(6) 2023, veryan received information via their swiss distributor (mcm medsys ag) relating to an event that occurred at a swiss healthcare facility relating to a biomimics 3d stent system (bm3d).The information reported to veryan stated that on (b)(6), while the user was deploying a bm3d stent, it was reported that it broke (interpreted as fractured by the veryan team while awaiting further information).There was no patient harm reported as a result of the event and no impact on the patient.There is very little detail available at present but veryan are awaiting further information on this event.

Event Description

On 04-dec-23, veryan received information via their swiss distributor (mcm medsys ag) relating to an event that occurred at a swiss healthcare facility relating to a biomimics 3d stent system (bm3d).The information reported to veryan stated that on (b)(6) 23, while the user was deploying a 5.0 x 150 mm bm3d stent, it was reported that it broke (interpreted as fractured by the veryan team while awaiting further information).There was no patient harm reported as a result of the event and no impact on the patient.There is very little detail available at present but veryan are awaiting further information on this event.

Manufacturer Narrative

The investigation is in progress.The device is being returned to veryan.Any additional information that becomes available will be provided in a follow-up supplemental report.

Event Description

On 04-dec-23, veryan received information via their swiss distributor (b)(4) relating to an incident that occurred at a swiss healthcare facility relating to a biomimics 3d stent system (bm3d).The information reported to veryan stated that on (b)(6) 2023, while the user was deploying a 5.0 x 150 mm bm3d stent to treat the right distal superficial femoral artery (sfa) the device fractured.The target lesion was described as a highly calcified occlusion.The physician's intention was to treat this occlusion by sub-intimal recanalisation.A contralateral approach was used with a 6 french (fr) access sheath and terumo stiff bent and 0.018" advantage guidewires.Initially, both the iliac vessels were treated with balloon angioplasty using armada balloon catheters.Two bentley stents, a 10 x 28 mm and a 10 x 38 mm were implanted bilaterally in the common iliac vessels before the advancement of the bm3d device.The bentley stents were implanted using a "kissing technique", which implied contact between the stents proximally at the aortic bifurcation.The physician proceeded to treat the distal sfa beginning with subintimal recanalisation of a long vessel segment.A navicross support catheter was used with the terumo stiff bent and 0.018" advantage guidewires which were used to access the subintimal space.A bentley beback catheter was used to allow re-entry to the vessel lumen distal to the occlusion.Multiple balloon angioplasties were performed using a 4 mm and 5 mm balloons.An attempt was made to deploy the bm3d stent in the target lesion so that the stent would transition the vessel lumen and subintimal space that had been created.The physician experienced resistance after approximately 2 cm of the stent had been revealed from the outer braid.As a result of the increased deployment force, the bifurcation hub to the outer braid bond separated.A partial deployment had occurred.The physician attempted to complete the stent deployment by pulling the bm3d delivery system proximally.This resulted in stent elongation and ended with the stent fracturing leaving separated crowns in the vessel.The physician completed the procedure with multiple balloon angioplasties at the target site using a 5 mm balloon device as well as a lutonix 5 x 220 mm drug-coated balloon (dcb).

Manufacturer Narrative

1.Device history record (dhr) review: 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.2.Returned device evaluation: the device was returned for evaluation.There was a separation between the bifurcation hub and the outer braid bond.Stent crowns were protruding from the distal end of the outer braid which confirmed the stent fractured.The outer braid was elongated when measured.The device was manufactured as intended.An attempt to deploy the stent resulted in the deployment of the remaining stent crowns successfully.The returned stent was seen to have 40 intact crowns and one fractured crown, which indicated that seven crowns remained within the patient.3.Angiographic image review: images and video of the procedure were provided to the investigation team.They were not the angiographic image files but were taken via smartphone.The image files show the subintimal space used to recanalise the occlusion.The sub-intimal space is a path created to enable the recanalisation of the occlusion.The images also showed the fractured and separated stent crowns following the partial deployment of the complaint device.Stent elongation was visible, which confirms the feedback that was provided by the physician.Furthermore, severe calcification can be seen within the target vessel.Additionally, the expansion of the stent crowns via dcb can be seen.The video displayed stent elongation and the subsequent fracture of the bm3d device as a result of the movement of the delivery system.4.Complaint conclusion: the physician elected to use a sub-intimal recanalisation to treat the distal sfa.The subintimal space created was much narrower than the vessel lumen.Therefore, the reduced lumen size likely contributed to the increased deployment force seen in this case.A reduced lumen size can create increased friction between the delivery system components, and between the delivery system and guide/introducer sheath during the stent deployment.Additionally, the calcification seen distal to the subintimal lumen also likely contributed to the increased deployment force.The investigation concluded that the reduced lumen size and difficult anatomical conditions are the root cause of the resistance noted during deployment which led to the partial deployment.Movement of the delivery system prior to full deployment can cause stent-related complications; elongation, and/or stent fracture which were seen in this case.The complaint was categorised as a "partial deployment, stent elongation and stent fracture".The cause category assigned was "anatomy".The reported complaint was not related to a deficiency of the device.Section b.5.Was updated with additional information, section g.6.And h.4.Were updated to reflect this report type (follow-up 02), section h.3.Was updated to reflect the device evaluation and section h.11.Was updated to reflect the investigation conclusions.

• 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: 18323591
• MDR Text Key: 330432392
• Report Number: 3011632150-2023-00144
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850312
• UDI-Public: (01)05391526850312(17)241210(11)230512(10)0000217219
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 145276-05
• Device Lot Number: 0000217219
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2023
• 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