MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME-18; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	181347HFRM-V
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformance's 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 available but has not been returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental report.The instructions for use (ifu) identifies premature coil detachment as potential complications associated with use of the device.
Event or Problem Description
As reported, a 13mm x 47 cm hydroframe 18 was then inserted into the microcatheter.Excessive resistance was felt when inserting this coil and when attempts were made to remove the coil it detached in the microcatheter.The jailed headway duo was then unable to be used to deliver further coils to the aneurysm resulting in sub optimal treatment of the target.It is not possible to retreat with further coils due to the flow diverting stent insitu so the patient will be monitored at regular follow up intervals and a decision will be made as to whether they require additional treatment and if so, the nature of that treatment will be determined in the future.No patient injury reported, however the incident has resulted in an incomplete treatment of a large aneurysm and limited the options for further treatment of the lesion.The patient is stable.
Additional Manufacturer Narrative
The investigation of the returned coil system found the implant to be slightly stretched and wavy at the proximal end, which is consistent with the coil experiencing resistance within the microcatheter as described in the reported event.However, the implant was found to still be attached to the pusher.The investigation of the returned device did not find any damage or other anomaly that would have caused or contributed to the reported premature detachment.The physical evaluation of the device could not identify the conditions or circumstances that led to the stretched implant, but stretching is consistent with the device experiencing forces exceeding the implant's yield strength.The microcatheter used with the coil system during the procedure was found to be flattened at approximately 16cm from the distal tip, which may have caused or contributed to the resistance described in the reported event.
Event or Problem Description
See h11 for product investigation results.

• Brand Name: HYDROFRAME-18
• 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: 22734334
• Report Number: 2032493-2025-90378
• Device Sequence Number: 7189058
• Product Code: KRD
• UDI-Device Identifier: 00810170015175
• UDI-Public: (01)00810170015175(11)221220(17)271130(10)0000301841
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 181347HFRM-V
• Device Lot Number: 0000301841
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2022
• 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