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

Catalog Number 131816-06

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/06/2020

Event Type  malfunction  

Manufacturer Narrative

At present, veryan's complaint investigators are still progressing with the investigation.As the device relating to this medical device report was contaminated during use with covid-19 blood , it was discarded at the clinical site and therefore will not be returning to veryan for inspection.Although there was no consequence to the patient or impact on the patient, veryan have decided to report this event to fda due to the lack of information available at present on this particular case.Once veryan's investigators have finalised their investigation, the conclusions will be provided to fda within 30 days of veryan's awareness.Veryan have initiated a capa request number (b)(4) to avoid recurrence of this issue.The supplemental mdr form will immediately follow this submission.There is no impact to the reporting decision arising from this error.

Event Description

On the (b)(6) 2020 veryan received a complaint in relation to an event occurring on the (b)(6) 2020 at (b)(6).It was reported by the vascular assistant to a veryan representative as follows: "the product was removed from the packaging for use and presented to dr.(b)(6) in sterile condition.During the preparation of the stent for implantation dr.(b)(6) noticed the bent tip at the distal end.This product was then returned to the vascular assistant with request for a complaint.The product has been contaminated with blood of a covid-19 patient and dr.(b)(6) has instructed to discard this product." there was no impact to the patient according to the information provided to veryan.

Manufacturer Narrative

This mdr supplemental is related to mdr 3011632150-2020-00030.Following an enquiry to the clinical site involved for more information it was confirmed that: 1) the device was removed from the packaging with the misshapen distal tip.2) two more images were provided from the site, the first was a higher resolution of the initial image provided and the second image was taken from a different angle.This provided a clearer image of the misshapen tip.3) as the device was removed from the packaging, and observed to already have a misshapen tip it would not indicate use error in this instance.4) an enquiry was raised with the supplier who is responsible for assembling the finished product on veryan's behalf.This was to ascertain if the misshapen tip could be explained due to a manufacturing defect/processing anomaly.5) on 22nd may an internal investigation was implemented by that supplier.On the 09-june-2020 contact was made to obtain an update on the progress of the internal investigation.No new information has been provided to date.6) a detailed lot history review revealed no issues that were deemed relevant to this complaint or its associated investigation.7) once veryan obtain updated information from the supplier on the ongoing internal investigation this information will be reviewed, and an addendum will be drafted to supplement the complaint investigation report.8) once any new or additional information is provided on the internal investigation from our supplier we will provide a further supplemental submission to fda.9) the complaint category (as found) has been assigned as "misshapen distal tip".10) the root cause cannot be established and therefore a cause category of "unknown" has been assigned to this complaint.The investigation to date indicates that the misshapen distal tip is not due to use error and as the device was removed from the packaging in this misshapen state, the defect points towards a manufacturing or processing issue.The device problem is addressed in the risk management file and documented in the labelling under "precautions" where device inspection is required prior to use.11) as veryan are still awaiting an update from the supplier, as their investigation is still ongoing the result code provided 3233-"results pending completion fo investigation" is still the most appropriate.The conclusion code has been updated from 11-"conclusion not yet available" with 4315-"cause not established" there were no patient details e.G.Demographics such as age,weight,ethnicity provided during this investigation other than that the device was contaminated with blood suspected of harbouring covid-19 and was discarded at the site and not returned for evaluation.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Type of Device: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL; unit 11 galway technology park; parkmore road; galway, H91 V E0H; EI H91 VE0H
• MDR Report Key: 10295819
• MDR Text Key: 200454755
• Report Number: 3011632150-2020-00030
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P180003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 131816-06
• Device Lot Number: 0000008140
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1