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

Model Number	142122-10
Medical Device Problem Codes	Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2022
Type of Reportable Event	Malfunction
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 device was not returned for evaluation and there were no angiographic imaging made available.The anatomical conditions were reported as challenging due to the tight bifurcation angle encountered but the iliacs were not reported as tortuous.It was stated that the bifurcation hub did not reach the proximal pin luer while attempting the deployment and that no section of the stent was unsheathed.The bonds were reported as being intact.The resistance experienced during the attempted deployment would suggest that there was a significant deployment force required to initiate the deployment of the stent possibly due to the anatomical condition of the vessels.Challenging anatomical conditions like the tight bifurcation angle reported can create increased friction between the device components of the delivery system and also between the delivery system and the introducer sheath.The ifu states the following "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." the significant deployment force experienced is a possible result of the challenging anatomical conditions encountered.The complaint was categorised as "unable to deploy".The exact root cause could not be established.
Event or Problem Description
A veryan representative was made aware of a report from a physician where a 6 x 100mm biomimics 3d vascular stent system would not deploy.The target site was the distal superficial femoral artery (sfa) and was prepared using laser atherectomy and balloon angioplasty.There was a tight bifurcation angle reported.There was also resistance felt at initiation of deployment.The device was removed and another biomimics 3d stent was used to finish the procedure.There was resistance at initiation of deployment of the second device but it was described as not noticable in comparison to the initial device used.The device was not returned for evaluation.There was no impact to the patient and the physician reported the patient outcome as good.The device was not returned for evaluation and no angiographic imaging was made available.

• 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 city, H91 V-E0H ; EI H91 VE0H
• MDR Report Key: 15050580
• Report Number: 3011632150-2022-00053
• Device Sequence Number: 14831559
• Product Code: NIP
• UDI-Device Identifier: 05391526850459
• UDI-Public: (01)05391526850459(17)230702(11)211201(10)0000123388
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/19/2022

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 Expiration Date: 07/02/2023
• Device Model Number: 142122-10
• Device Catalogue Number: 142122-10
• Device Lot Number: 0000123388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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