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

Model Number	7110-0254
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Stroke/CVA (1770); Paraplegia (2448)
Date of Event	03/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: hydrosoft coil migrated after successful balloon assisted coiling intervention from the same left a1 aneurysm.The a2 did not have flow for several minutes and the total time until full flow was restored was a total of 1 hour; this resulted in a stroke.Dr.Did not perform stent assisted coiling because the correct length device was not on their shelf and he did not want to cover the anterior choridal.Dr.Tried to retrieve the coil with a thrombus retrieval device (2 passes) and small microsnare along with aspiration.The decision was made to utilize a stent 2.5x23 (172020) to keep the coil alongside a1 segment vessel wall and restore flow.A1 experienced vessel spasm, but no evidence of any damage confirmed with in suite cta.The patient after waking up could not move his right leg or arm and was aphasic.Symptoms started to improve.Patient is currently talking and able to move his right hand, the right leg is still not moving.
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 implanted and therefore not available for return and investigation by the manufacturer.However, medical imaging was provided and will be reviewed.The investigation is ongoing and upon completion of the investigation, a supplemental mdr will be submitted.
Event or Problem Description
As reported: hydrosoft coil migrated after successful balloon assisted coiling intervention from the same left a1 aneurysm.The a2 did not have flow for several minutes and the total time until full flow was restored was a total of 1 hour; this resulted in a stroke.Dr.Did not perform stent assisted coiling because the correct length device was not on their shelf and he did not want to cover the anterior choridal.Dr.Tried to retrieve the coil with a thrombus retrieval device (2 passes) and small microsnare along with aspiration.The decision was made to utilize a stent 2.5x23 to keep the coil alongside a1 segment vessel wall and restore flow.A1 experienced vessel spasm, but no evidence of any damage confirmed with in suite cta.The patient after waking up could not move his right leg or arm and was aphasic.Symptoms started to improve.Patient is currently talking and able to move his right hand, the right leg is still not moving.
Additional Manufacturer Narrative
Twenty radiographic images and one video were provided for review.They are not labeled as to date or time.These images show the coil mass migrating distally from the a1 origin to the first a2 bifurcation point, as described in the reported event.However, without the return and physical evaluation of the device, the investigation cannot further examine if a condition existed that would have contributed to the reported event.

• Brand Name: HYDROSOFT-3D-AV
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• 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: 21748453
• Report Number: 2032493-2025-90035
• Device Sequence Number: 15825595
• Product Code: KRD
• UDI-Device Identifier: 00816777025425
• UDI-Public: (01)00816777025425(11)230116(17)271231(10)0000310494
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K161367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7110-0254
• Device Lot Number: 0000310494
• Was Device Available for Evaluation?: No
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2023
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male