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

Model Number	100817HFRM-V-A2
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, it is indicated that the coil device was released before reaching the aneurysm.The patient is reported to be fine.No harm was reported.
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 stated to be available for evaluation but has not yet been returned to the manufacturer for evaluation.The alleged product issue could not be confirmed.If the device is returned at a later date, an investigation will be performed and a supplemental report will be submitted with the findings.The instructions for use (ifu) identifies premature coil detachment as potential complications associated with use of the device.
Event or Problem Description
The complaint sample was returned for evaluation.
Additional Manufacturer Narrative
Evaluation of the physical device: items returned for evaluation: pusher; implant.Items not returned for evaluation: introducer; microcatheter.The visual analysis of the returned device found that the implant was not attached to the pusher.The implant was returned stretched at the proximal section and separated from the pusher.The investigation of the pusher found that the monofilament was broken, which indicates that the device experienced a tensile break.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 implant stretching, but it is consistent with the device experiencing forces exceeding the implant's yield strength.The microcatheter used in the procedure was not returned, so the investigation could not determine if it had caused or contributed to the reported complaint.

• Brand Name: HYDROFRAME-10-AV
• Common Device Name: NEUROVASCULAR EMBOLIZATION COIL
• 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: 20164293
• Report Number: 2032493-2024-00666
• Device Sequence Number: 17970070
• Product Code: HCG
• UDI-Device Identifier: 00816777023582
• UDI-Public: (01)00816777023582(11)230713(17)280630(10)0000392346
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 100817HFRM-V-A2
• Device Lot Number: 0000392346
• 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: 08/28/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2023
• 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: Female