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

Model Number 7110-0204-3D-A2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hydrocephalus (3272); Speech Disorder (4415)

Event Date 06/21/2022

Event Type  Injury  

Manufacturer Narrative

Items returned: - n/a.Visual analysis: 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 was not provided for this investigation.Investigation findings: 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 device¿s 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.Batch review: 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.Complaint system review: there are no similar complaints based on the complaint category regarding this batch number from the last two years recorded in the complaint system at the time of this investigation.Ifu review (additional information can be found in the ifu): please refer to the japanese ifu for precautions, warnings, and further information.The following is taken from the english version: 6.Detachment of the coil 6-1 place the detachment controller removed from the protective packaging in a clean field.Caution·do not detach the coil using any power source other than the detachment controller.6-2 connect the proximal end of the pusher catheter to the detachment controller by firmly inserting the proximal end of the pusher catheter into the funnel section of the detachment controller.Observe the state of the light 3 seconds after connecting.Caution ·if the pusher catheter is not connected properly, the controller will not activate.·since the controller does not have an on/off switch, do not press the side button of the detachment controller.·keep blood and contrast away from the proximal end of pusher catheter.If there appears to be blood or contrast, wipe with sterile water or heparinized saline solution before connecting to the detachment controller.[detachment controller may not work properly.] ·if a red light appears or if the light does not appear, replace the detachment controller.6-3 when the detachment controller is properly connected to the pusher catheter, a single audible tone will sound and the light will turn green to signal that it is ready to detach the coil.6-5 push the detachment button to detach and deploy coil.When the button is pushed, an audible tone will sound and the light will flash green.6-6 at the end of the detachment cycle, three audible tones will sound and the light will flash yellow three times.This indicates that the detachment cycle is complete.Verify detachment of the coil by first loosening the rhv valve, then pulling back slowly on the delivery system and verifying that there is no coil movement.If the coil does not detach during the detachment cycle, re-insert the pusher catheter into the controller and attempt another detachment cycle when the light turns green.Caution the light will turn red after the 20 cycles of detachment, so if the red light comes on before the detachment operation, discard the detachment controller and replace it with a new one.·if it does not detach after the third attempt, remove the delivery system and replace.The reported event is non-verifiable.The physical device was not available for evaluation to determine if a condition existed that would have caused or contributed to event.Supplemental imaging was not provided for review; without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.This information may be updated if additional information is provided at a later date.

Event Description

It was reported through the rage clinical study that the following event was possibly related to the study device.The subject presented with a chief complaint of headache.Computed tomography angiogram (cta) review showed right posterior communicating artery aneurysm and mild obstructive hydrocephalus.The patient underwent diagnostic cerebral angiogram and successful coil embolization of their aneurysm.Post procedure, the patient had encephalopathy and aphasia.Repeat head ct( computerized tomography) showed increased hydrocephalus from baseline mild hydrocephalus.The neurosurgeon was consulted and evaluated the subject, who had since returned to baseline with resolution of encephalopathy and aphasia with holding of sedating agents.Ae outcome : resolved without sequelae.

• Brand Name: HYDROSOFT-3D-AV
• Type of Device: 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: 18824207
• MDR Text Key: 336736642
• Report Number: 2032493-2024-00186
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777025388
• UDI-Public: (01)00816777025388(11)211222(17)261130(10)0000140812
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7110-0204-3D-A2
• Device Lot Number: 0000140812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Female