MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME-10-AV; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	7110-0405-A2
Medical Device Problem Codes	Unraveled Material (1664); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the embolization coil was used to treat a patient with an acomm aneurysm.Reportedly, it was difficult to advance the coil and the physician attempted to pull the coil back into the sheath when the coil started to unravel and would not go back into the sheath.The coil was removed from the patient and the case was aborted as the coil could not be placed in the aneurysm.No coils were implanted during the case.Reportedly, vessel anatomy was the main reason why physician was unable to treat the aneurysm.At the end of procedure, the patient was the same as pre procedure and currently "baseline." the physician plans to bring the patient to surgery to clip the aneurysm; however, no date is set.
Additional Manufacturer Narrative
The device was returned to the manufacturer for analysis and the investigation is ongoing.Upon completion of the investigation, a supplemental mdr report will be submitted.
Additional Manufacturer Narrative
Correction: d2a, d2b and g5.The investigation found the pusher returned with no implant attached.The implant was not returned.Further investigation found the heater coil pet melted and the pusher's monofilament with a mushroom shape, indicating that the implant was detached via thermal activation.As the implant was not returned, the investigation could not test for or further assess the alleged unraveling and resistance issues.The microcatheter used in the procedure was not returned, so the investigation could not determine if it had caused or contributed to the reported event.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.

• Brand Name: HYDROFRAME-10-AV
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• 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: 24743085
• Report Number: 2032493-2026-00207
• Device Sequence Number: 9376628
• Product Code: KRD
• UDI-Device Identifier: 00816777023650
• UDI-Public: 00816777023650
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K132952
• 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): 04/27/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7110-0405-A2
• Device Lot Number: 0000906758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2026
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2025
• 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: HEADWAY DUO MICROCATHETER (MICROVENTION)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown