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

Model Number	7110-1036-A2
Medical Device Problem Codes	Unraveled Material (1664); Premature Separation (4045)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: embolization coil unraveled and broke apart, is retained inside the left ica of patient.
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 implanted in the patient and not returned to the manufacturer for evaluation.Procedural or medical imaging was not provided.Without the return and physical evaluation of the device, the investigation is unable to determine if a condition existed that would have caused or contributed to the reported event.

• Brand Name: HYDROFRAME-10-AV
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING 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: 25219921
• Report Number: 2032493-2026-00323
• Device Sequence Number: 9801989
• Product Code: KRD
• UDI-Device Identifier: 00816777023766
• UDI-Public: 00816777023766
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K132952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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: 7110-1036-A2
• Device Lot Number: 0001521612
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2026
• 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: Other
• Patient Sex: Unknown