MAUDE Adverse Event Report: MICROVENTION, INC. HYPERSOFT 3D-AV; Neurovascular Embolization Device

Model Number	100306HS-V-A2
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation findings: 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.Without imaging, the investigation cannot further verify if the event occurred as described, nor could the investigation further evaluate the cause of the reported event.Based on a review of the device¿s risk documentation, the reported event did not indicate there were the presence of 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 an 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: based on a review of the last 2 years of complaint data, and at the time of this investigation, no systemic issues have been identified for this batch number that would have caused or contributed to the reported event.Ifu review (additional information can be found in the ifu): potential complications: potential complications include but are not limited to: hematoma at the site of entry, vessel perforation, aneurysm rupture, parent artery occlusion, incomplete aneurysm filling, emboli, hemorrhage, ischemia, vasospasm, coil migration or misplacement, premature or difficult coil detachment, clot formation, revascularization, post-embolization syndrome, and neurological deficits including stroke and possibly death.Cases of chemical aseptic meningitis, edema, hydrocephalus and/or headaches have been associated with the use of embolization coils in the treatment of large and giant aneurysms.The physician should be aware of these complications and instruct patients when indicated.Appropriate patient management should be considered.Warnings and precautions: the mcs is intended for single use only.Do not resterilize and/or reuse the device.After use, dispose in accordance with hospital, administrative and/or local government policy.Do not use if the packaging is breached or damaged.The mcs must be delivered only through a wire-reinforced microcatheter with a ptfe inner surface coating.Damage to the device may occur and necessitate removal of both the mcs and microcatheter from the patient.Do not advance the v trak® delivery pusher with excessive force.Determine the cause of any unusual resistance, remove the mcs and check for damage.Advance and retract the mcs device slowly and smoothly.Remove the entire mcs if excessive friction is noted.If excessive friction is noted with a second mcs, check the microcatheter for damage or kinking.If repositioning is necessary, take special care to retract the coil under fluoroscopy in a one-to-one motion with the v trak® delivery pusher.If the coil does not move in a one-to-one motion with the v trak® delivery pusher, or if repositioning is difficult, the coil may have become stretched and could possibly break.Gently remove and discard the entire device.Due to the delicate nature of the mcs coils, the tortuous vascular pathways that lead to certain aneurysms and vessels, and the varying morphologies of intracranial aneurysms, a coil may occasionally stretch while being maneuvered.Stretching is a precursor to potential coil breakage and migration.If resistance is encountered while withdrawing a coil that is at an acute angle relative to the microcatheter tip, it is possible to avoid coil stretching or breaking by carefully repositioning the distal tip of the catheter at, or slightly inside, the ostium of the aneurysm.By doing so, the aneurysm and artery act to funnel the coil back into the microcatheter.Introduction and deployment of the mcs: 20.Seat the distal tip of the introducer sheath at the distal end of the microcatheter hub and close the rhv lightly around the introducer sheath to secure the rhv to the introducer.Do not over-tighten the rhv around the introducer sheath.Excessive tightening could damage the device.21.Push the coil into the lumen of the microcatheter.Use caution to avoid catching the coil on the junction between the introducer sheath and the hub of the microcatheter.22.Push the mcs through the microcatheter until the proximal end of the v trak® delivery pusher meets the proximal end of the introducer sheath.Loosen the rhv.Retract the introducer sheath just out of the rhv.Close the rhv around the v trak® delivery pusher.Slide the introducer sheath completely off of the v trak® delivery pusher.Use care not to kink the delivery system.24.Under fluoroscopic guidance, slowly advance the mcs coil out the tip of the microcatheter.Continue to advance the mcs coil into the lesion until optimal deployment is achieved.Reposition if necessary.If the coil size is not suitable, remove and replace with another device.If undesirable movement of the coil is observed under fluoroscopy following placement and prior to detachment, remove the coil and replace with another more appropriately sized coil.Movement of the coil may indicate that the coil could migrate once it is detached.Do not rotate the v trak® delivery pusher during or after delivery of the coil into the aneurysm.Rotating the mcs v trak® delivery pusher may result in a stretched coil or premature detachment of the coil from the v trak® delivery pusher, which could result in coil migration.Angiographic assessment should also be performed prior to detachment to ensure that the coil mass is not protruding into the parent vessel.Investigation conclusion: the physical device was not available for evaluation to investigate if a condition existed that would have contributed to event.Supplemental imaging was also unavailable for review; without imaging, the investigation cannot verify the event occurred as described, nor could the investigation further examine the cause of the reported event.
Event or Problem Description
It was reported that the concerned embolization coil was being used in conjunction with a coil-assist stent to treat a patient with a left pcom aneurysm using "jailing" technique.After placing the stent (ref.Mfr report#: 2032493-2026-08049), the physician started coiling the aneurysm with the concerned coil and reportedly noted that the 3cm proximal radiopaque marker was missing from the coil.The physician used fluoroscopy to assess whether the coil was inside the aneurysmal sac in order to detach it, as this can be misleading at certain angles.The physician could see when the coil was on the tip of the microcatheter for the detachment zone.The coil was detached and implanted in the aneurysm.The patient was doing very well after the procedure and was able to move both arms and legs; and able to answer usual questions.This is event report 2 of 2.

• Brand Name: HYPERSOFT 3D-AV
• Common Device Name: 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: 25681827
• Report Number: 2032493-2026-08050
• Device Sequence Number: 4797356
• Product Code: HCG
• UDI-Device Identifier: 00816777024114
• UDI-Public: (01)00816777024114(11)221219(17)271130(10)0000301141
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K091641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 100306HS-V-A2
• Device Lot Number: 0000301141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Supplement Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 07/01/2026
• Supplement Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HEADWAY 17 MICROCATHETER (MICROVENTION).; HEADWAY DUO MICROCATHETER (MICROVENTION).; LVIS EVO STENT (MICROVENTION).
• Patient Sex: Female