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

Model Number	7118-1644
Medical Device Problem Codes	Stretched (1601); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Serious Injury
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 has been returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Event or Problem Description
As reported: during treatment of a large sidewall aneurysm, using a microcatheter 156, fully delivered the hydroframe coil, but it would not detach with two detachment controllers.Sequence of events: deployed half of a flow diverter, coiled, then more flow diverter deployed, but not fully deployed.They pulled the coil out and it stretched and detached.According to them, "no loops in pusher wire." finished deploying the flow diverter, had 5-6mm of the clot retriever to try and retrieve the coil, but it did not work.Finally, there were able to pull the microcatheter into the benchmark; they visualized the pusher wire in the benchmark and used a snare to get all of the coil.No patient injury, physician said patient is good.
Event or Problem Description
As reported: during treatment of a large sidewall aneurysm, using a microcatheter 156, fully delivered the hydroframe coil, but it would not detach with two detachment controllers.Sequence of events: deployed half of a flow diverter, coiled, then more flow diverter deployed, but not fully deployed.They pulled the coil out and it stretched and detached.According to them, "no loops in pusher wire." finished deploying the flow diverter, had 5-6mm of the clot retriever to try and retrieve the coil, but it did not work.Finally, there were able to pull the microcatheter into the benchmark; they visualized the pusher wire in the benchmark and used a snare to get all of the coil.No patient injury, physician said patient is good.
Additional Manufacturer Narrative
The investigation of the returned coil system found the implant stretched and separated from the pusher; however, no indications of activation using a detachment controller was found on the pusher heater coil.The investigation found the pusher's monofilament with a tensile break shape at the tip, which is consistent with the device experiencing force that exceeded the strength of the monofilament causing the implant to separate from the pusher.The physical evaluation of the device could not identify the conditions or circumstances that led to the stretched implant, but the damage is consistent with the device experiencing forces exceeding the implant's yield strength.The returned detachment controllers were found to function as intended and would not have caused or contributed to the alleged detachment issue.

• Brand Name: HYDROFRAME-18-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: 21658060
• Report Number: 2032493-2025-00238
• Device Sequence Number: 20940221
• Product Code: KRD
• UDI-Device Identifier: 00816777024015
• UDI-Public: (01)00816777024015(11)241031(17)290930(10)0000756965
• 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
• 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): 03/28/2025

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: 7118-1644
• Device Lot Number: 0000756965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2025
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2024
• 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 156; PIPELINE; V-GRIP (LOT 0000164858)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male