MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY 21+; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	MC212156S-AL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
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 not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed at this time.If the device or additional information is received, microvention, inc., will submit a supplemental mdr report.
Event or Problem Description
As reported, this was an embolization procedure for a large unruptured left carotid-ophthalmic aneurysm.There were two successive attempts to deploy two silk 4.75x20mm flow diverter stents, but these did not open properly in the distal section and could not be recaptured by the microcatheter.A second flow diverter stent (from another manufacturer) was then deployed, this time with good stent placement.Current patient status: classified as c due to significant increase in procedure duration: approximately 1 hour above average.No consequences for the patient, patient monitored, discharged from hospital with no post-operative consequences detected.Actions taken in the healthcare facility to treat the patient: monitoring.The report is being submitted based on the increased procedure time.
Additional Manufacturer Narrative
The investigation of the returned microcatheter found the distal end curved.No damage or any other anomaly was observed on any other section of the device.An in-house stent was inserted into the microcatheter and was able to deploy from and retract into the microcatheter without resistance during the investigation; furthermore, no issues were found with the expansion of the in-house stent.No procedure imaging was provided to further assess the alleged issue of the stent being incapable of retracting into the microcatheter.The stents used in the procedure were not returned for evaluation, so the investigation could not determine if they had caused or contributed to the reported complaint.
Event or Problem Description
A supplemental report is being submitted to report the investigation findings.See h11.

• Brand Name: HEADWAY 21+
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: 24531489
• Report Number: 2032493-2026-00152
• Device Sequence Number: 18409852
• Product Code: DQO
• UDI-Device Identifier: 00842429117484
• UDI-Public: (01)00842429117484
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120917
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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 Model Number: MC212156S-AL
• Device Lot Number: 0001119163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2025
• 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: SILK FLOW DIVERTER (2), BALT.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown