MAUDE Adverse Event Report: MICROVENTION, INC HYDROFILL-10-AV; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	100206HFIL-V-A2
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2023
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 was stated to be available for return to the manufacturer for evaluation but has not yet been returned.The premature detachment and event as described could not be confirmed.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.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 that during balloon assisted coiling of a acom aneurysm while using a microcatheter, the coil detached prematurely, causing it to be partially deployed within the aneurysm and partially within the microcatheter.A balloon was already in position and was used to maneuver the coil to the ica.The coil was then snared using a stent retriever.The patient is stable and there were no issues caused by coils.
Additional Manufacturer Narrative
The visual analysis and investigation of the returned items found the pusher coils severely stretched and tangled at the distal section.The investigation found the implant's monofilament to be broken, which indicates the device experienced a tensile break.The implant was returned severely stretched at the proximal section, damaged, deformed, and separated from the pusher.The implant's monofilament showed a tensile break shape at the tip, which is consistent with the device experiencing excessive 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 damage, but the damage is consistent with the device experiencing forces over specification.The microcatheter used in the procedure was not evaluated as a part of this evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.
Event or Problem Description
No additional information was received.

• Brand Name: HYDROFILL-10-AV
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• 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: 16534995
• Report Number: 2032493-2023-00615
• Device Sequence Number: 17640528
• Product Code: HCG
• UDI-Device Identifier: 00816777023261
• UDI-Public: (01)00816777023261(11)220601(17)270531(10)0000202224
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112226
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2023

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 Model Number: 100206HFIL-V-A2
• Device Catalogue Number: 100206HFIL-V
• Device Lot Number: 0000202224
• 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: 02/28/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown