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

Model Number UNKNOWN

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/21/2022

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances associated with this part/lot number combination could not be performed as this information was not available or provided at the time this.The remains of the coil was reported to be available for return to the manufacturer for evaluation, but has not yet been returned.The alleged product issue / 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.

Event Description

It was reported that the 3x8 coil was inserted into the aneurysm through a microcatheter and after about 4 attempts both doctors agreed to change to a smaller 3x6 coil.Upon retracting the 3x8 coil, the coil did not come out.The physician was instructed to stop pulling the coil and to take out the microcatheter and the coil together.The coil was successfully removed.The 3x6 coil was inserted through the microcatheter and into the aneurysm.On their final runs, the physicians noted a distal clot and after several attempts to aspirate with a catheter, a trevo stent retriever, and a solitaire, they could not get it all out.Some of the clot was removed, but it traveled distally, and they opted to stop trying to continue to get more, as they felt it kept pushing the clot further along.It was reported that the patient was in the icu and not doing well post-procedure.

Manufacturer Narrative

The investigation of the returned coil system found the hypotube kinked, and the implant coils stretched and damaged with deformed loops.The pusher was returned severely stretched at the distal section and broken at the transition area, which is consistent with the alleged product issue.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 retraction forces over specification, as described in the reported event.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 Description

Please see h10 for investigation conclusion.

• Brand Name: HYDROSOFT-3D-AV
• Type of Device: 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: 15973401
• MDR Text Key: 305415619
• Report Number: 2032493-2022-00548
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161367
• 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,Followup
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention