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

Catalog Number 144700-19

Device Problems Break (1069); Material Separation (1562); Stretched (1601); Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 09/05/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On the (b)(6) 2023, a physician attempted to deploy a 7.0 x 150 mm biomimics 3d stent (bm3d) via pedal anterior tibial artery (ata) access into the proximal superficial femoral artery (sfa) when the pull back portion of the sheath broke.The physician reported that the ata was previously occluded and tight around the sheath which was probably a factor in leading to the reported sheath break.The physician was able to retract the sheath and finish the deployment but it was reported as being very elongated afterwards.It was reported by the physician as being patent afterwards through a previously occluded sfa.The physician reported that he may have to bring the patient back and stent through it.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.It was known that the bifurcation hub to outer braid bond of the device separated during the procedure.The failure of the bond is suggestive of a high deployment force present during the deployment.It was noted that resistance was experienced upon initiation of deployment and that an increase in resistance occurred as the physician continued the deployment attempt.The instruction for use (ifu) states "warning: if unexpected resistance is felt at the start of the deployment, do not force the movement of the bifurcation luer; instead, carefully withdraw the sds without deploying the stent.".There is a potential for a partial deployment if the user continues to deploy the stent after experiencing resistance as occurred in this case.Difficult anatomical conditions e.G.; calcification, tortuous anatomy, narrowing of the vessel can also create friction between the delivery system components and between the delivery system and the introducer sheath during deployment.This friction can manifest as increased deployment force which can lead to delivery system damage in this case separation of the bifurcation hub to the outer braid.It was reported that there was a tight narrowing of the anterior tibial artery (ata) in this case.This was likely a cause of the resistance which led to the high deployment force culminating in the partial deployment.Angiographic images from the procedure were not provided in this case and the anatomical conditions of the vessel cannot be fully established.The stent elongation was a result of the removal of the delivery system from the patient while the stent was partially deployed.The complaint was categorised as "partial deployment, stent elongation" and the cause categories assigned were "anatomy" and "user".The reported complaint was not related to a deficiency of the device.

Event Description

On the (b)(6) 2023, a physician attempted to deploy a 7.0 x 150 mm biomimics 3d stent (bm3d) via pedal anterior tibial artery (ata) access to treat the proximal superficial femoral artery (sfa).The patient anatomy was reported as having a narrow lumen at the proximal sfa and minimal calcification.The pedal approach also had a tight narrowing of the ata.A 5fr and 6fr slender access sheaths were used with a cook amplatz 0.035" extra stiff guidewire.Before the stent implantation, the target vessel was treated using a 6 mm angioplasty balloon using a pedal approach.The device was flushed in line with the instructions for use (ifu).The device was introduced into the patient and the physician experienced some issues advancing the bm3d device through the tight narrowing of the ata but managed to advance the device to the proximal sfa.The physician removed slack from the delivery system and deployment was initiated while keeping the proximal pin luer in a fixed position.The physician experienced resistance immediately upon initiation of deployment and before the release of any stent crowns from the outer braid.The physician continued to deploy the stent despite the resistance experienced and the physician managed to deploy approximately half of the length of the bm3d stent.It was noted that the resistance increased as the physician continued the deployment.The increased deployment force resulted in the separation of the outer braid from the bifurcation hub which resulted in the partial deployment.The physician began to remove the delivery system and as the device was being pulled back the remaining stent deployed in the vessel.The stent was elongated and its length was roughly 40% longer than the 150 mm stent length.The outcome of the procedure was that the target vessel had been revascularized.However, it was noted that there was minimal lumen diameter gain as a result of the stent elongation that occurred.The physician has indicated that the patient will have an additional procedure to deploy another stent in the proximal sfa.The physician's office stated there was no harm to the patient.

Event Description

On (b)(6) 2023, a physician attempted to deploy a 7.0 x 150 mm biomimics 3d stent (bm3d) via pedal anterior tibial artery (ata) access to treat the proximal superficial femoral artery (sfa).The patient's anatomy was reported as having a narrow lumen at the proximal sfa and minimal calcification.The pedal approach also had a tight narrowing of the ata.A 5 french (fr) and 6 fr slender access sheaths were used with a cook amplatz 0.035" extra stiff guidewire.Before the stent implantation, the target vessel was treated using a 6 mm angioplasty balloon using a pedal approach.The device was flushed in line with the instructions for use (ifu).The device was introduced into the patient and the physician experienced some issues advancing the bm3d device through the tight narrowing of the ata but managed to advance the device to the proximal sfa.The physician removed slack from the delivery system and deployment was initiated while keeping the proximal pin luer in a fixed position.The physician experienced resistance immediately upon initiation of deployment and before the release of any stent crowns from the outer braid.The physician continued to deploy the stent despite the resistance experienced and the physician managed to deploy approximately half of the length of the bm3d stent.It was noted that the resistance increased as the physician continued the deployment.The increased deployment force resulted in damage and separation of the proximal outer braid into two separate portions which resulted in the partial deployment.The physician began to remove the delivery system and as the device was being pulled back the remaining stent deployed in the vessel.The stent was elongated and its length was roughly 40% longer than the 150 mm stent length.The outcome of the procedure was that the target vessel had been revascularized.However, it was noted that there was minimal lumen diameter gain as a result of the stent elongation that occurred.The physician has indicated that the patient will have an additional procedure to deploy another stent in the proximal sfa.The physician's office stated there was no harm to the patient.Additional information was received in the form of two images which were reviewed by the complaint investigation team and this review was finalised on (b)(6) 2024.The first image was of the device outer carton and the second image was of the complaint device following its removal from the patient.The proximal portion of the outer braid in this image was split into two separate portions.Initially, the fracture reported was interpreted to have been a separation of the outer braid to bifurcation hub however the image has established that this was damage and separation of the proximal outer braid.There was no additional information provided.

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.It was known that the proximal outer braid of the device was damaged and separated into two separate portions during the procedure.The damage and separation of the proximal outer braid were suggestive of a high deployment force present during the deployment.It was noted that resistance was experienced upon initiation of deployment and that an increase in resistance occurred as the physician continued the deployment attempt.The instruction for use (ifu) states "warning: if unexpected resistance is felt at the start of the deployment, do not force the movement of the bifurcation luer; instead, carefully withdraw the sds without deploying the stent.".There is a potential for a partial deployment if the user continues to deploy the stent after experiencing resistance as occurred in this case.Difficult anatomical conditions e.G.; calcification, tortuous anatomy, and narrowing of the vessel can also create friction between the delivery system components and between the delivery system and the introducer sheath during deployment.This friction can manifest as increased deployment force which can lead to delivery system damage in this case the proximal outer braid was damaged and separated into two separate portions.It was reported that there was a tight narrowing of the anterior tibial artery (ata) in this case.This was likely a cause of the resistance which led to the high deployment force culminating in the partial deployment.Angiographic images from the procedure were not provided in this case and the anatomical conditions of the vessel cannot be fully established.Two additional images were provided following the completion of the initial investigation.One of these images was of the device's outer carton and the other image was of the complaint device following its removal from the patient.The stent elongation was a result of the removal of the delivery system from the patient while the stent was partially deployed.The complaint was categorised as "partial deployment, stent elongation" and the cause categories assigned were "anatomy" and "user".The reported complaint was not related to a deficiency of the device.Section b.5.Was updated to reflect the additional information received on 07-mar-24, sections g.6.And h.2.Were updated to reflect the type of report (follow-up 02) and the reason and section h.11.Was updated to include the details of the proximal outer braid damage and separation identified on the returned image that was received following the completion of the initial investigation.The conclusions of the initial investigation remain unchanged.

• 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: 17864972
• MDR Text Key: 325836900
• Report Number: 3011632150-2023-00119
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850527
• UDI-Public: (01)05391526850527(17)240702(11)221202(10)0000187088
• 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,Followup
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 144700-19
• Device Lot Number: 0000187088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2022
• 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