MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT-3D-AV; NEUROVASCULAR EMBOLIZATION COIL

Model Number	100306HFRM-V-3D-A2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
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.However, the device has not yet been returned to the manufacturer for evaluation.An investigation could not be performed and the alleged product issue could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental report will be submitted with the investigation results and conclusions.
Event or Problem Description
It was reported that an embolization coil implant detached unexpectedly during treatment of a giant aneurysm.The distal portion of the coil was left in the aneurysm and the proximal portion was removed with the delivery pusher, as it was still attached to the pusher.There was no intervention or patient injury.
Additional Manufacturer Narrative
The investigation of the returned coil system found that the pusher was returned with no implant attached.However, no indications of activation using a detachment controller were found on the pusher heater coil.The implant was not returned for evaluation as the distal section remained inside the patient's body as described in the reported event.Consequently, the investigation could not verify the location of the proximal portion of the implant since no implant was attached to the pusher upon receipt.The investigation found the pusher's monofilament with 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
It was reported that an embolization coil implant detached unexpectedly during treatment of a giant aneurysm.The distal portion of the coil was left in the aneurysm and the proximal portion was removed with the delivery pusher, as it was still attached to the pusher.There was no intervention or patient injury.

• Brand Name: HYDROSOFT-3D-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: 17119212
• Report Number: 2032493-2023-00788
• Device Sequence Number: 7032310
• Product Code: HCG
• UDI-Device Identifier: 00816777026576
• UDI-Public: (01)00816777026576(11)230216(17)280131(10)0000324995
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

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: 100306HFRM-V-3D-A2
• Device Catalogue Number: 100306HFRM-V
• Device Lot Number: 0000324995
• 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: 06/01/2023
• Supplement Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown