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

Catalog Number 145276-05

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/19/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is in progress.Any additional information that is made available will be provided in a follow-up supplemental report.

Event Description

On (b)(6) 2023, a physician was using a 5 x 150 mm biomimics 3d stent system (bm3d) during a procedure and reported that the stent fractured while the device was being retracted.A piece of the stent remained in the patient.The physician dilated it and used a gore viabahn device to finalise the procedure.The patient required extra monitoring and the events led to a significant extension in the procedure time.

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 bm3d device was returned to veryan with the remaining stent still in the delivery system.The distal tip of the device was fully retracted to the outer braid, the bonds of the delivery system were still intact, and the stroke length of the device was still present.The returned device had a significant cast which caused curl up of the delivery system when left unrestrained.A kink was noted in the proximal outer braid of the delivery system which coincided with the end of the stiff support shaft that is part of the inner sub assembly.The cast and kink was believed to be due to the way the device was packaged for return.A second kink could be seen in the outer braid 410 mm from the distal edge of the strain relief.There were fractured stent crowns noted projecting from the distal outer braid.The distal part of the device was examined under the microscope.The distal tip was free from damage but the radiopaque marker was partially torn.The outer braid length was measured and was considered to be elongated.The kink seen in the outer braid 410 mm from the distal edge of the strain relief coincided with damage to the inner shaft of the device.The bonds of the system were checked and intact.An attempt was made to deploy the remaining stent, the device had to be aligned as straight as possible to reduce any potential friction created by the cast and noted kinks.The proximal pin luer was secured and the bifurcation hub was retracted along the support shaft.There was successful release of the stent with little resistance noted.The stent was rinsed and expanded as expected.The stent included twenty-seven (27) undamaged crowns and two (2) fractured crowns.A 5 x 150 mm stent possesses forty-eight (48) crowns, therefore 19 crowns had separated during use.The angiographic images from the procedure were provided by the site.The right sfa and total occlusion in the vessel prior to the vessel preparation were observed.The occlusion was present throughout the sfa as reported.Due to the occlusion the sfa showed run off into the ancillary vessels.A balloon angioplasty was performed in the proximal sfa.It is important to note that the balloon was unable to obtain total expansion due to the condition of the vessel.Another image displayed multiple points of vessel lumen narrowing, calcification and vessel dissections in the sfa after vessel preparation with balloon angioplasty.The partially deployed stent was observed in an image taken after deployment and the stent was elongated in the proximal region.An image taken after deployment of the competitor viabahn device showed that it was implanted in overlap with the bm3d stent.It was reported that resistance was experienced during deployment and prior to full release of the bm3d stent.The outer braid elongation noted in the returned device was suggestive of a significantly high deployment force present.Veryan's risk management file reflects that there is a potential risk when the user encounters increased force during deployment which include the potential for delivery system damage, partial deployment and/or clinically relevant stent fractures.The partially deployed stent crowns fractured during deployment and separated from the device.The separation of the stent crowns occurred during the delivery system withdrawal following the partial deployment.The risk management file also reflects that there is the potential for a clinically relevant stent fracture when the device is removed after a portion of the stent has been released from the outer braid.Difficult anatomical conditions of the vessel including occlusion can create increased friction between the device components and between the delivery system and the guide/introducer sheath during stent deployment.This friction can lead to increased deployment forces as was seen with this case.It was noted that following vessel preparation the target site was accessed without any issues but the vessel anatomical details from the images (narrowing and calcification) could have contributed to the high deployment forces reported in this case.The patient anatomy was most likely the root cause of the partial deployment.The angiographic imaging showed that the separated stent crowns became elongated within the target vessel upon removal of the bm3d delivery system and this can occur if the device is removed prior to full release of a stent.The complaint was categorised as a "partial deployment, stent elongation" with a cause category of "anatomy" assigned.The reported complaint was not related to a deficiency of the device.Sections b.5., g.6., h.6.And h.10.Have been updated.

Event Description

On (b)(6) 2023, a physician was using a 5 x 150 mm biomimics 3d stent system (bm3d) to treat the right superficial femoral artery (sfa).The patient's vessel anatomy also had a total occlusion throughout the entire sfa.A contralateral approach was taken, and there were no issues noted in gaining access to the target vessel.The entire sfa was treated using balloon angioplasty.The bm3d was then introduced into the patient and advanced to the target site without any complications.The physician attempted to deploy the stent but reportedly experienced resistance.It was noted that a portion of the stent was released from the outer braid during the attempted deployment.The physician was unable to deploy the entire length of the stent as the outer braid could not be retracted under the deployment force that was present.A partial deployment had occurred.The physician decided the remove the device which resulted in fracture and separation of the stent crowns which had been partially deployed.Following the removal of the bm3d device, an additional balloon angioplasty was performed and a competitor device (viabahn) was successfully placed and the procedure was finalised.The events led to a prolonged procedure and the need for additional patient monitoring.

• 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: 18065192
• MDR Text Key: 327295446
• Report Number: 3011632150-2023-00134
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850312
• UDI-Public: (01)05391526850312(17)250413(11)230913(10)0000256767
• 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: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• 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: 0000256767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2023
• 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
• Patient Sex: Female