MAUDE Adverse Event Report: MICROVENTION, INC. VIA-17 MICROCATHETER; PERCUTANEOUS CATHETER

Model Number	VIA-17-154-01-MVI2
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	02/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances associated with this 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 at the user facility and not returned to the manufacturer for evaluation; therefore, the reported event cannot be confirmed.The instructions for use (ifu) identifies aneurysm rupture as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during treatment of aneurysm on the left ica (carotid t), the implantation of a web device was planned.During the attempt to cannulate the aneurysm, the control over the via-17 microcatheter was lost and the device moved forward and perforated the aneurysm due to a steep angle from the parent vessel to the aneurysm.It was decided to use a web device for a quick treatment of the bleeding.The first web device did not fit to the aneurysm and was removed.The web was replaced but the web and via were removed from the patient due to placement difficulty.The aneurysm was coiled successfully.The coils deployed partially through the perforation.The hemorrhage was stopped, but the aneurysm was not treated successfully.The patient did have an evd because of the hemorrhage two weeks prior.For this reason the anesthesiologist was able to drain a certain amount of blood from the brain.After the examination, a ct was performed revealing swelling of both ventricles.The neurosurgeon decided against an operation to place a second evd, because the patient was stable and the hemorrhage stopped.

• Brand Name: VIA-17 MICROCATHETER
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 13865100
• Report Number: 2032493-2022-00964
• Device Sequence Number: 20157614
• Product Code: DQY
• UDI-Device Identifier: 00842429106402
• UDI-Public: (01)00842429106402(11)210218(17)240228(10)21021816C
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K150894
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/23/2022

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: 02/28/2024
• Device Model Number: VIA-17-154-01-MVI2
• Device Catalogue Number: VIA-17-154-01
• Device Lot Number: 21021816C
• 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: 02/23/2022
• Initial Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: WEB SL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female