MAUDE Adverse Event Report: MICROVENTION INC HYPERSOFT 3D-ADVANCED; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	8410-0306-A2
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported: during treatment of acutely ruptured acomm aneurysm, a scepter xc was placed in right m2 branch and a headway 17 microcatheter was placed into the bilobed aneurysm.Successful delivery of 3 terumo neuro coils was performed with balloon inflation without incident.The fourth coil was attempted to place with repositioning of the coil into the existing coil mass 3-4 times.The physician realized the coil had stretched and decided to take a snare over the headway 17 microcatheter and was able to successfully retrieve the stretched coil out of the patient.The coil was never detached.It had stretched and was still partially in the aneurysm sac upon retrieval.The indwelling coil mass was unaffected by the removal of the stretched coil.No further intervention was required.The patient was admitted to the hospital with subarachnoid hemorrhage (sah); it was pre-existing and not caused by the procedure.They are unable to tell condition / outcome currently and no update on patient condition is available as of report date.
Additional Manufacturer Narrative
A search for non-conformances associated with the reported 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 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.
Additional Manufacturer Narrative
Investigation conclusion: the investigation of the returned coil system found the implant to be stretched and broken at the proximal end.Further inspection found the pusher heater coil kinked.The portion of the implant distal to the break site was found to be partially stuck within the microcatheter.The stretched condition of the implant is consistent with the coil becoming stuck or experiencing friction during repositioning within the target site (i.E., stuck on previously implanted coils or the tip of the microcatheter).The physical evaluation of the device could not identify the conditions or circumstances that led to the heater coil kink, but the damage is consistent with the device experiencing forces exceeding the pusher's yield strength.The physical evaluation of the device could not identify the conditions or circumstances that led to the broken implant, but the damage is consistent with the device experiencing forces exceeding the implant's tensile strength.The microcatheter used during the procedure was returned cut at the distal section and flattened at 5cm from the distal tip, which may have caused or contributed to the reported complaint.
Event or Problem Description
No additional incident information was received, however the device was returned and evaluated.Please see d10, h3, h6 and h11.

• Brand Name: HYPERSOFT 3D-ADVANCED
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING 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: 21965064
• Report Number: 2032493-2025-90134
• Device Sequence Number: 8160563
• Product Code: KRD
• UDI-Device Identifier: 00816777021267
• UDI-Public: (01)00816777021267(11)241220(17)291130(10)0000836921
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K161452
• 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): 06/13/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8410-0306-A2
• Device Lot Number: 0000836921
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZ GOOSE NECK MICROSNARE KIT -UNKNOWN DETAILS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female