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

Model Number	7110-0208-3D-A2
Medical Device Problem Codes	Unraveled Material (1664); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	12/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
No additional information was received.
Additional Manufacturer Narrative
Investigation conclusion: the investigation of the returned coil system found the pusher bodycoil stretched at the distal section with the lead wires broken and exposed, and the implant stretched and broken, which is consistent with the alleged product issue.The pusher heater coil was found burnt, indicating thermal detachment did occur.The portion of the implant distal to the break site was not returned for evaluation.The stretched and broken condition of the pusher and implant is consistent with the device experiencing force that exceeded the tensile strength of the pusher and implant causing the lead wires and implant to separate in two pieces.The microcatheter used in the procedure was not returned for evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.
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 returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Event or Problem Description
It was reported: during a neuro procedure involving an aneurysm coiling, the patient experienced an intra-procedural stroke.It appears that the coil completely unraveled, and one of the wires detached, which caused blood to adhere to it and contributed to the stroke.They were able to recover the broken wire using trevo and successfully completed the procedure with a thrombectomy.The patient is doing well.No other information was provided.

• Brand Name: HYDROSOFT-3D
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): MICROVENTION INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer (Section G): MICROVENTION INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 21103813
• Report Number: 2032493-2025-00041
• Device Sequence Number: 9171681
• Product Code: HCG
• UDI-Device Identifier: 00816777025401
• UDI-Public: (01)00816777025401(11)241003(17)290930(10)0000722278
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K080666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 7110-0208-3D-A2
• Device Lot Number: 0000722278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2025
• 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: 12/12/2024
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown