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

Model Number 144700-19

Device Problems Break (1069); Fracture (1260); 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 04/05/2022

Event Type  malfunction  

Manufacturer Narrative

The complaint investigation is ongoing.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 is returning for evaluation but has not yet been received.If further information regarding this event becomes available, or the investigation is concluded, a follow-up report will be submitted.

Event Description

On the (b)(6) 2022 a stent was being implanted using a contralateral approach to treat a lesion in the distal sfa.A 6fr sheath and 0.035" amplatz guidewire were used.The aortic bifurcation angle was reported as moderate but there were no device issues or resistance experienced while crossing the aortic bifurcation with the biomimics 3d delivery system.There was resistance reported during advancement of the delivery system to the target site and also during initiation of deployment of the stent.About 3-4cm of the stent was deployed before the physician decided to remove the delivery system and partially deployed stent.Upon removal of the device, the stent broke and a fragment remained in the patient's vessel.The physician was able to dilate the fragment of the stent remining in the vessel.A second non biomimics device was used.There was also resistance felt during advancement and deployment of this stent and it also fractured upon deployment.The patient was discharged with no issues.The patient was scheduled to come in for a follow-up appointment the next day, but did not make this appointment.The clinical site spoke with the patient and there are no consequences or impact to the patient reported.

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 complaint investigation included an evaluation of the returned device and communication with the physician that was involved with the case.The additional information received from the site in response to questions from the complaints team highlighted that a contralateral approach was used.The vessel preparation included laser atherectomy and balloon angioplasty.A 6 french (fr) access sheath was used along with a 0.035" amplatz guidewire.A long chronic total occlusion (cto) was located between the origin of the superficial femoral artery (sfa) to the popliteal artery.There was a moderately tight aortic bifurcation.Resistance was experienced during advancement of the device and at initiation of the stent deployment and was probably linked to the moderate tortuosity of the vessels which were identified on the angiographic images.The ifu states "do not force passage if resistance is encountered at any time during delivery of the sds.This may cause damage to the stent, the sds, or vessel or may lead to partial deployment.If the stent cannot be deployed, remove the entire delivery system (a partially deployed stent may require surgical removal)".The stent partially deployed 3-4 cm although the physician reported that the bifurcation hub had been retracted to the proximal pin luer of the delivery system suggesting there was no stroke length remaining.The returned device showed no kinking or casting in the device and all bonds were in tact.There was significant elongation of the outer braid.The outer braid elongation is usually associated with high deployment forces.The elongation of the outer braid resulted in the partial deployment.A portion of the stent broke off during removal of the delivery system and remained in the vessel.This portion was was expanded using a balloon and the patient was dicharged.The complaint investigation was categorised as a "partial deployment and stent fracture type ii to type v".The cause category assigned was "anatomy".Section b.5 and section h have been updated to reflect he conclusions of the investigation.If any additional inofmration becaomes available a follow-up supplemental will be submitted.

Event Description

On the (b)(6) 2022 a stent was being implanted using a contralateral approach to treat a lesion in the distal sfa.A 6fr sheath and 0.035" amplatz guidewire were used.The aortic bifurcation angle was reported as moderate but there were no device issues or resistance experienced while crossing the aortic bifurcation with the biomimics 3d delivery system.There was resistance reported during advancement of the delivery system to the target site and also during initiation of deployment of the stent.About 3-4cm of the stent was deployed before the physician decided to remove the delivery system and partially deployed stent.Upon removal of the device, the stent broke and a fragment remained in the patient's vessel.The physician was able to dilate the fragment of the stent remaining in the vessel.The patient was discharged with no issues.The patient was scheduled to come in for a follow-up appointment the next day, but did not make this appointment.The clinical site spoke with the patient and there are no consequences or impact to the patient reported.

• 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: 14250998
• MDR Text Key: 290458900
• Report Number: 3011632150-2022-00020
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850527
• UDI-Public: (01)05391526850527(17)230901(11)230131(10)0000129505
• 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
• Report Date: 06/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2023
• Device Model Number: 144700-19
• Device Catalogue Number: 144700-19
• Device Lot Number: 0000129505
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2023
• 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