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

Model Number	7110-0510-A2
Medical Device Problem Codes	Material Fragmentation (1261); Unintended Movement (3026)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/27/2024
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 partial device was stated to be available for return to the manufacturer for evaluation but has not yet been returned.The alleged breakage, premature separation issue and incident as described could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.
Event or Problem Description
It was reported: the previous 3 coils went in fine through the headway duo.They then attempted to place a hydroframe 5x10 coil.This coil ended up pushing out the headway duo past the fred x that was fully deployed and could not advance back over the coil.In the effort to remove the coil completely, it stretched and broke.The coil was left behind in the patient jailed against the fred x placed in the aneurysm.Multiple attempts to obtain additional incident information were made, however, no information has been received at time of this report.
Event or Problem Description
It was originally reported: the previous 3 coils went in fine through the headway duo.They then attempted to place a hydroframe 5x10 coil.This coil ended up pushing out the headway duo past the fred x that was fully deployed and could not advance back over the coil.In the effort to remove the coil completely, it stretched and broke.The stretched coil was left behind in the patient jailed against the fred x placed in the aneurysm.Additional information received notes the coil was left behind and the devices were removed radially through the access sheath.They tried to snare some of the stretched coil in the axillary but were unsuccessful.They left this behind, held manual pressure and closed / completed procedure.The distal portion of the coil is jailed against the fred x, the remainder of the stretched coil was left free inside the patient.Patient recovered from procedure "fine" per md response to reporter.
Additional Manufacturer Narrative
Investigation conclusion: the investigation of the returned coil system found no implant attached to the pusher.Further inspection found the pusher bodycoil stretched and broken.The implant was not returned for evaluation as it remained in the patient as described in the reported event.The attachment monofilament was not present in the pusher.Without the return and evaluation of the implant and monofilament, the investigation is unable to determine the mode of separation (i.E., unintentional vs normal detachment using a detachment controller), nor could the investigation determine if the implant was stretched as described in the reported event.Since the investigation could not verify the mode of implant separation due to the absence of the implant and monofilament, the reported event is considered non-verifiable.The physical evaluation of the device could not identify the conditions or circumstances that led to the stretched and broken pusher, but this damage is consistent with the device experiencing forces exceeding the pusher's yield and tensile strength.

• Brand Name: HYDROFRAME 10 ADVANCED
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICROVENTION INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer (Section G): MICROVENTION INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 21161590
• Report Number: 2032493-2025-00065
• Device Sequence Number: 18250985
• Product Code: KRD
• UDI-Device Identifier: 00816777023674
• UDI-Public: (01)00816777023674(11)240720(17)290630(10)0000658436
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K090357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

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: 7110-0510-A2
• Device Lot Number: 0000658436
• 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: 12/27/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRED X, DETAILS UNKNOWN.; HEADWAY DUO, DETAILS UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown