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

Model Number	142122-07
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6)2024, a physician was using a biomimics 3d (bm3d) 7.0 x 80 mm device to treat a patient.It was reported that the stent was partially deployed prior to introducing it on the guidewire.The physician reported that they were uncertain if the event related to the device.There was no impact to the patient reported.
Additional Manufacturer Narrative
The investigation is in progress.If any additional information becomes available a supplemental/follow-up report will be submitted.
Event or Problem Description
On (b)(6)2024, a physician was using a biomimics 3d (bm3d) 7.0 x 80 mm device to treat a patient.It was reported that the stent was partially deployed prior to introducing it on the guidewire.The physician reported that they were uncertain if the event related to the device.There was no impact to the patient reported.The investigation was finalised on 11-feb-25 and determined this event as premature stent release due to user handling error and is not related to a deficiency of the device.
Additional 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.On (b)(6)2024 it was reported that a physician discarded a 7x80 mm biomimics 3d device following the premature release of 2-3 mm of stent crowns during a procedure on (b)(6)2024.It is understood that both the physician and the lab technician became aware that 2-3mm of stent crowns were protruding from the distal end of the outer braid at the moment that they were introducing the device to its guidewire.Based on the investigation of the returned device, as well as a manufacturing record review, this investigation concludes that this complaint is not associated with a deficiency with the device.The feedback given in this case states that both the physician and the lab technician became aware that 2-3mm of stent crowns were protruding from the distal end of the outer braid at the moment that they were introducing the device to its guidewire.It is therefore suspected at this time that the stent crowns may have been released during the device handling before the attempt to insert the device onto the guidewire.Veryan is aware that any forward movement of the support shaft can cause the unintended release of stent crowns.Ufmeca-1 version 18.0 line items # 60-66 detail the potential hazardous situations associated with premature stent deployment as a result of forward movement of the support shaft.Therefore, if the support shaft had been moved forward during the handling before the attempt to insert the device onto the guidewire, this is a fitting root cause for the 2-3 mm of stent crowns which were prematurely released from the outer braid in this case.Additionally, ufmeca-1 version 18.0 line items #15-16 detail the potential for device issues and the device being discarded as a result of user handling errors as prolonged procedure, in this case, the physician does not believe there was any clinically significant extension in procedure time.This investigation considers the root cause of this complaint as potentially the device handling that occurred before/during the attempt to introduce the device to its guidewire and concluded that the cause category of user should be assigned.Veryan is aware that any forward movement of the support shaft can cause the unintended release of stent crowns.It is important to note that ifu-3 version 4.0 gives multiple cautions to prevent the use of the device in the scenario in which stent crowns are prematurely released from the outer braid.In this case, the physician elected to discard the complaint device and therefore acted in accordance with the instructions of the ifu.There was no impact to the patient.Section b.5.Was updated with additional information recieved, section g3 was updated, sections g.6.And h.2.Were updated to reflect the report type (follow-up 01) and reason, section h.6.Was updated to align with investigation conclusions and section h.11.Was updated with results of the investigation to reflect the sections changed in this report.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Common Device Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL LIMITED; 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: 21065161
• Report Number: 3011632150-2024-00063
• Device Sequence Number: 8484674
• Product Code: NIP
• UDI-Device Identifier: 05391526850435
• UDI-Public: (01)05391526850435(17)250703(11)231203(10)0000285343
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P180003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/03/2025
• Device Model Number: 142122-07
• Device Catalogue Number: 142122-07
• Device Lot Number: 0000285343
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown