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

Model Number	142122-09
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint investigation is ongoing.The device is being returned for evaluation.If further information regarding this event becomes available, or the investigation is concluded, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2021, a physician at the surgical clinic of nashville was attempting to position a biomimics 3d (5mm x 100mm) in the mid superficial femoral artery for deployment.This was a pedal access site and as the biomimics 3d was traversing the bend of the anterior tibial vessel, the physician observed that the stent began to flower in the anterior tibial origin.The physician removed the biomimics 3d from the patient without issue and without damaging the stent.He then chose a non biomimics stent which passed to the sfa lesion and was successfully deployed.
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.The investigation included an evaluation of the returned device and a review of information provided on the case.The angiographic images could not be made available.Following evaluation of the returned device the following were identified: that there were stent struts protruding from the distal end of the outer braid confirming the physician's initial report of the event.It was confirmed that ten stent crowns had been released.The device displayed no cast or distortion of the outer braid.No damage was observed to any other components of the device including the distal braid, guidewire lumen and the distal tip.The length of outer braid was measured and was within specification.All bonds were intact.The tuohy borst valve was also unaffected.The remaining stent crowns were deployed on a benchtop without any issues.The complaint highlighted that the device was used via a pedal access and tracked through a tight bend in the anterior tibial artery.It is possible that friction created by the anatomy could have restricted movement of the outer braid and led to partial deployment.It is also possible that if the physician inadvertently advanced the pin end of the delivery system while the outer braid was restricted this too could lead to partial deployment of the stent even with the tuohy borst valve closed.The complaint was categorized as "premature stent release" and a cause category of "anatomy" was assigned.The reported complaint is not related to a deficiency of the device.If any additional information is provided a follow-up report will be submitted.Section b.1.Has been updated and section h.6.Adverse event coding has been updated to reflect the findings and conclusion of the investigation.
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.The investigation included an evaluation of the returned device and a review of information provided on the case.The angiographic images could not be made available.Following evaluation of the returned device the following were identified: that there were stent struts protruding from the distal end of the outer braid confirming the physician's initial report of the event.It was confirmed that ten stent crowns had been released.The device displayed no cast or distortion of the outer braid.No damage was observed to any other components of the device including the distal braid, guidewire lumen and the distal tip.The length of outer braid was measured and was within specification.All bonds were intact.The tuohy borst valve was also unaffected.The remaining stent crowns were deployed on a benchtop without any issues.The complaint highlighted that the device was used via a pedal access and tracked through a tight bend in the anterior tibial artery.It is possible that friction created by the anatomy could have restricted movement of the outer braid and led to partial deployment.It is also possible that if the physician inadvertently advanced the pin end of the delivery system while the outer braid was restricted this too could lead to partial deployment of the stent even with the tuohy borst valve closed.The complaint was categorised as "premature stent release" and a cause category of "anatomy" was assigned.Additional information was provided by the clinical site in response to a request for further information from the complaints investigation team as the initial investigation had not provided enough detail around the procedure.There was limited information available at the time the investigation was completed in relation to the advancement of the stent delivery system (sds) and who was in contact with it during advancement.This additional information highlighted the following : the physician was responsible for advancement of the device.There were two other people with control of the device while on the support wire.The luer was held while the advancement of the delivery system was taking place.The sds was advanced while by holding the outer braid close to the access point.The physician feels that there could have been some force applied to the luer/inner shaft during deployment.It is possible that during the advancement of the device, if a force was applied to the luer/inner shaft as highlighted by the physician's response this could have resulted in the premature flowering of the biomimics stent.As a result of the additional information the complaint category of "premature stent release" has not changed however the cause category of "user" has been added as well as "anatomy".Section h - investigation conclusions has been updated to reflect this.The reported complaint is not related to a deficiency of the device.If any additional information is provided a follow-up report will be submitted.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Common Device Name: 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, H91 V-E0H ; EI H91 VE0H
• MDR Report Key: 12907176
• Report Number: 3011632150-2021-00047
• Device Sequence Number: 4081090
• Product Code: NIP
• UDI-Device Identifier: 05391526850442
• UDI-Public: (01)05391526850442(17)220906(11)210205(10)0000070518
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/06/2022
• Device Model Number: 142122-09
• Device Catalogue Number: 142122-09
• Device Lot Number: 0000070518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2020
• Supplement Date Received by Manufacturer: 01/07/2022; 03/04/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 01/31/2022; 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2021
• 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