MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME-18-AV; EMBOLIZATION COIL

Model Number	180931HFRM-V-A2
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the coil had detached on its own.Physician was performing a stent coil repair of basilar tip aneurysm.Lvis jr deployed in right p1 and hw duo jailed.Hw duo slipped back into basilar.Was unable to resheath coil or advance hw duo over the coil.Physician used microsnare to retrieve coil.Finished coiling by crossing lvis jr.There was no patient injury.
Additional Manufacturer Narrative
A search for non-conformance's 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 return to the manufacturer for evaluation, but has not yet been returned.The event 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.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.
Additional Manufacturer Narrative
Please note this follow up report is also being submitted to include correction from fei based to cfn based.Fei was selected in error on our initial report.A visual inspection of the device captured in this file could not be performed as a physical device was not returned for evaluation, nor were any images of the device provided in place of a device return.Procedure and medical imaging were not provided for this investigation.Without the return and physical evaluation of the device, the investigation cannot definitively determine if a condition existed that would have caused or contributed to the reported event.Without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.Based on a review of the devices risk documentation, the reported event did not indicate there were any potential or new manufacturing, design, quality, or other systemic issues, or non-conformances.The complaint code is monitored through the trending process; corrective action is determined, as needed, through this process.Investigations of historic complaint files with similar complaint category coding are recorded in the complaint handling system, without the ability to perform and analysis of the device, this investigation cannot identify with certainty any potential root causes.A search for non-conformances associated with this part and lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.There is 1 other complaint from the last 2 years recorded in the complaint handling system with this batch number at the time of this investigation.At the time of this investigation, no systemic issues have been identified for this batch number that would have caused or contributed to the reported event.The instructions for use identifies premature coil detachment as a potential complication associated with the use of the device.
Event or Problem Description
It was reported the coil had detached on its own.Physician was performing a stent coil repair of basilar tip aneurysm.Lvis jr deployed in right p1 and hw duo jailed.Hw duo slipped back into basilar.Was unable to resheath coil or advance hw duo over the coil.Physician used microsnare to retrieve coil.Finished coiling by crossing lvis jr.There was no patient injury.

• Brand Name: HYDROFRAME-18-AV
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656
• MDR Report Key: 15657884
• Report Number: 0002032493-2022-00500
• Device Sequence Number: 6436480
• Product Code: HCG
• UDI-Device Identifier: 00816777023803
• UDI-Public: (01)00816777023803(11)200522(17)250430(10)2005225P7
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100454
• 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): 01/13/2023

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 Expiration Date: 04/30/2025
• Device Model Number: 180931HFRM-V-A2
• Device Catalogue Number: 180931HFRM-V
• Device Lot Number: 2005225P7
• Was Device Available for Evaluation?: Yes
• 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: 10/18/2022
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2020
• 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: HW DUO; LVIS JR
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown