MAUDE Adverse Event Report: MICROVENTION, INC. VIA-33; CATHETER, PERCUTANEOUS

Model Number	VIA-33-133-01-MVI2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	01/09/2023
Type of Reportable Event	Death
Event or Problem Description
The company received a report regarding a procedure in which a web device was planned to be used, but was never utilized due to intervening patient complications.According to the report, a web device was planned to be used for the treatment of pericallosal/acomm with azygos a1 aneurysm.The physician experienced difficulty getting the via-33 catheter beyond the right ica terminus into a1.After two failed attempts, angiography revealed bleeding in the subarachnoid space.A balloon was prepped and utilized to help stop the bleed, and after noting the bleed continued, the case was aborted and an external ventricular drain (evd) was placed.The reported cause of the event was a combination of vessel tortuosity and fragile blood vessels.It was later reported that the patient passed away later at unknown date.
Additional Manufacturer Narrative
A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was discarded by the hospital and not available for return to the manufacturer, and images not available.Therefore, a product analysis could not be performed and the alleged product issue cannot be verified.If additional new information is received, microvention inc.Will submit a supplemental report.The instructions for use (ifu) identifies aneurysm/vessel perforation or rupture and neurological deficits including stroke and death as potential complications associated with use of the device.
Additional Manufacturer Narrative
Multiple requests for date of death, cause of death and images were made but no response received.Summary of concluded investigation: the device was not returned for evaluation and procedure and medical imaging were not provided for this investigation.Without the return and physical evaluation of the device, the investigation cannot definitively determine if a condition existed that would have caused or contributed to the reported event.Without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.Based on a review of the device¿s risk documentation, the reported event did not indicate there were any potential or new manufacturing, design, quality, or other systemic issues, or non-conformances.The complaint code is monitored through the trending process; corrective action is determined, as needed, through this process.Investigations of historic complaint files with similar complaint category coding are recorded in the complaint handling system.Without the ability to perform an analysis of the device, this investigation cannot identify with certainty any potential root causes.There are no similar complaints based on the complaint category regarding this batch number from the last two years recorded in the complaint system at the time of this investigation.

• Brand Name: VIA-33
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 16286146
• Report Number: 2032493-2023-00547
• Device Sequence Number: 4929781
• Product Code: DQY
• UDI-Device Identifier: 00842429106433
• UDI-Public: (01)00842429106433(11)220111(17)241231(10)0000139582
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K192135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: VIA-33-133-01-MVI2
• Device Catalogue Number: VIA-33-133-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2023
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2022
• 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: Death
• Patient Sex: Unknown