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

Catalog Number 142122-14

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); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2023, veryan was made aware of details of a procedure which was performed on (b)(6 )2023 involving a 6.0 x 125 mm biomimics 3d (bm3d) device.The target lesion was described as a tight stricture that was significantly calcified.The physician was able to successfully cross the lesion and prepare it using percutaneous transluminal angioplasty (pta) before using the bm3d device.After preparing and flushing the bm3d device, the physician was able to cross the target lesion without difficulty.Upon deployment, the physician noticed significant resistance and after fully pinning the delivery system, the stent had not fully deployed.The physician tried to free the stent from the delivery system but the stent broke off leaving roughly half of the stent in the superficial femoral artery (sfa).The physician then deployed a second bm3d stent without difficulty over the portion of the first stent to successfully correct the issue.There was no patient impact reported.

Event Description

On (b)(6) 2023, a physician attempted to treat the superficial femoral artery (sfa) and popliteal artery of a patient using a 6.0 x 125 mm biomimics 3d (bm3d) device.The target lesion was described as a tight stricture that was significantly calcified.The popliteal artery was also occluded.A contralateral approach was used using a 6f cook ansel access sheath and an amplatz extra-stiff guidewire.A 4 mm balloon angioplasty was used to prepare the target lesion.The bm3d device was flushed per the instructions for use (ifu) and introduced into the patient.The physician experienced difficulty advancing the device to the target through the narrow vessel and during the initiation of deployment immediately experienced resistance.The physician continued the deployment and managed to deploy roughly 30% of the stent despite the increasing resistance throughout the attempt.As a result of the increasing deployment force, the bifurcation hub reached the proximal pin luer before the full release of the stent.The physician was unable to deploy the remaining portion of the stent, therefore a partial deployment had occurred.The physician attempted to recapture the partially deployed stent but was unable to do so.This recapture attempt resulted in the fracture and separation of stent crowns.The physician decided to remove the bm3d device.The physician deployed a second bm3d stent without difficulty to expand the stent crowns of the portion of the first stent that remained in the vessel.The events led to a prolonged procedure.

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 device was evaluated and it was observed that fractured stent crowns protruded from the distal end of the outer braid.The returned device had a separation of the bifurcation hub to the outer braid bond.The returned device had a mild cast and kink in the proximal outer braid which coincided with the end of the stiff support shaft and these were believed to have been as a result of how the device was packaged before its return.The radiopaque marker of the distal outer braid was damaged which coincided with the fractured stent and protruding crowns.The radiopaque marker damage is believed to have been caused by the attempted recapture of the partially deployed stent.There was one fractured crown and 8 full crowns protruding from the distal end of the outer braid.There was no damage to the distal tip.The outer braid showed was elongated.The remaining device bonds were intact.The presence of manufacturing indicators indicated that the complaint device was manufactured as intended.The remaining stent was deployed without issue, rinsed and expanded.There were 36 crowns present and one fractured crown, so a portion of 3 crowns remained in the patient's vessel.The outer braid to bifurcation hub bond failure and outer braid elongation suggested that a high deployment force was present during deployment.The physician experienced resistance immediately after initiating deployment but continued to deploy the stent which is contrary to the instructions for use (ifu), which recommends that the device should be removed.Continuing the deployment may lead to instances that damage the device which can include partial deployment.Difficult vessel conditions e.G.Tortuous vessel anatomy, heavy calcification etc.Can create friction between the delivery system components as well as between the delivery system and the access sheath or guidewire.This friction can cause increased deployment forces and may lead to damage to the device.The conditions of the vessel likely led to the resistance however angiographic imaging was not provided so the exact condition of the vessels cannot be determined.The physician in this case attempted to recapture the partially deployed stent which is also contrary to the ifu and such attempts may lead to clinically relevant stent fractures.The complaint was categorised as a "partial deployment" with cause categories of "anatomy" and "user" assigned.The reported complaint is not related to a deficiency of the device.Sections b.5., d.9., g.6., 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; 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: 18354605
• MDR Text Key: 330872239
• Report Number: 3011632150-2023-00143
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850480
• UDI-Public: (01)05391526850480(17)240617(11)221117(10)0000182753
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

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 Catalogue Number: 142122-14
• Device Lot Number: 0000182753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2022
• 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