MAUDE Adverse Event Report: MICROVENTION, INC. VIA-27; CATHETER, PERCUTANEOUS

Model Number	VIA-27-154-01-AL
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was reported available for return but has not yet been received.Therefore, at this time, the product analysis could not be performed and the alleged product issue cannot be verified.If the device or additional new information is received, a supplemental report will be submitted.
Event or Problem Description
It was reported that embolization device was used in an unspecified procedure.Reportedly, the physician attempted to advance a the embolization device but the device would not advance through the microcatheter despite several attempts made.The device and the microcatheter were removed from the patient and the physician used a smaller size embolization device and a new microcatheter of the same model but encountered the same advancing challenge.After several attempts, the physician decided against interventional treatment and opted for surgery that was performed the following day.No further information was provided by the hospital.There was no report of harm or injury to the patient.
Additional Manufacturer Narrative
Additional information: d10 (date device returned), h11 (additional information).The device was returned to the manufacturer and its evaluation is not complete and is ongoing.A supplemental report will be submitted upon completion of investigation.Additional information has been received indicating vessel anatomy was not a factor in the event.Following day surgery completed using aneurysm clipping.Current patient status is unknown as no additional information provided by the hospital.
Additional Manufacturer Narrative
Investigation conclusion: the investigation of the returned via microcatheter found no damage or other anomaly that would have caused or contributed to the reported complaint.The investigation of the returned web system found the pusher bent and kinked, which could have contributed to the reported resistance; however, the device was able to advance and deploy through the via microcatheter without resistance during functional testing.The physical evaluation of the device could not identify the conditions or circumstances that led to the pusher damage, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: VIA-27
• 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: 20691807
• Report Number: 2032493-2024-00832
• Device Sequence Number: 8659302
• Product Code: DQO
• UDI-Device Identifier: 00842429118726
• UDI-Public: (01)00842429118726(11)240208(17)270131(10)0000505912
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 01/15/2025

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 Model Number: VIA-27-154-01-AL
• Device Lot Number: 0000505912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/02/2024
• Supplement Date Received by Manufacturer: 12/03/2024; 01/07/2025
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 12/16/2024; 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2024
• 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: 8X4 WEB ANEURYSM EMBOLIZATION (MICROVENTION, INC.); 9X4 WEB ANEURYSM EMBOLIZATION (MICROVENTION, INC.); VIA-27 MICROCATHETER (MICROVENTION, INC.)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female