MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME-10-AV; DEVICE NEUROVASCULAR EMBOLIZATION

Model Number	100833HFRM-V-A2
Medical Device Problem Codes	Unraveled Material (1664); Separation Failure (2547); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Serious Injury
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 not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed at this time.Case images were provided that are currently pending review conclusion.If the device or additional information is received, microvention, inc., will submit a supplemental mdr report.The instructions for use (ifu) identifies coil stretching as potential complications associated with use of the device.
Event or Problem Description
As reported, the coil did not detach.The physician decided to remove it, especially since its positioning did not really suit him.During removal, the coil appeared as stretched: it was impossible to push or pull it.By using successively a lasso, a solitaire and a balloon to trap the coil, the physician managed to remove a large part of the stretched coil and finally decided to leave the rest in the aneurysm and the artery.Additional information indicated: the physician put an atlas stent: 3/24mm before the first hydroframe coil that has stretched.The coil was then put through the cells of the stent.The patient condition was reported to be good.
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.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: there are no similar complaints based on the complaint category regarding this batch number from the last two years recorded in the complaint system at the time of this investigation.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 hes 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 hes 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 hes 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 hes and check for damage.¿ advance and retract the hes device slowly and smoothly.Remove the entire hes if excessive friction is noted.If excessive friction is noted with a second hes, 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 hes 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 hes 19.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.20.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.Initiate timing using a stopwatch or timer at the moment the device enters the microcatheter.Detachment must occur within the specified reposition time.21.Push the hes 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.To prevent premature hydration of the hes, ensure that there is flow from the saline flush.24.Under fluoroscopic guidance, slowly advance the hes coil out the tip of the microcatheter.Continue to advance the hes 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 hes 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.25.Complete the deployment and any repositioning so that the coil will be detached within the reposition time specified in table 1.After the specified time, the swelling of the hydrophilic polymer may prevent passage through the microcatheter and damage the coil.If the coil cannot be properly positioned and detached within the specified time, simultaneously remove the device and the microcatheter.Detachment of the hes coil 33.When the v grip® detachment controller is properly connected to the v trak® delivery pusher, a single audible tone will sound and the light will turn green to signal that it is ready to detach the coil.If the detachment button is not pushed within 30 seconds, the solid green light will slowly flash green.Both flashing green and solid green lights indicate that the device is ready to detach.If the green light does not appear, check to ensure that the connection has been made.If the connection is correct and no green light appears, replace the v grip® detachment controller.35.Push the detachment button.When the button is pushed, an audible tone will sound and the light will flash green.36.At the end of the detachment cycle, three audible tones will sound and the light will flash yellow three times.This indicates that the detachment cycle is complete.If the coil does not detach during the detachment cycle, leave the v grip® detachment controller attached to the v trak® delivery pusher and attempt another detachment cycle when the light turns green.37.The light will turn red after the number of detachment cycles specified on the v grip® labeling.Do not use the v grip® detachment controller if the light is red.Discard the v grip® detachment controller and replace it with a new one when the light is red.38.Verify detachment of the coil by first loosening the rhv valve, then pulling back slowly on the delivery system and verifying that there is no coil movement.If the implant did not detach, do not attempt to detach it more than two additional times.If it does not detach after the third attempt, remove the delivery system.Procedure/medical information review: imaging review, p25-1720, md, (b)(6) 2025: two radiographic images are supplied.They are not labeled as to time or date.Both are unsubtracted single shots, and i don¿t know for sure where the aneurysm that is being treated is.The event description does not specify the aneurysm location.From the wire and catheter position, i assume the aneurysm is an acom.P25-1720 image 1: ap unsubtracted single-shot radiograph, no contrast.There is an atlas stent spanning from the left a2 to the left a1.A microcatheter is seen with its tip in a medium-sized acom aneurysm.A loose coil mass is seen in the aneurysm.A coil has been partially deployed, and its proximal portion is seen, intact, inside the microcatheter, to the level of the distal supraclinoid ica; proximal to that, the coil is stretched, unraveled.The proximal end of the unraveled coil is not included on the radiograph.P25-1720 image 2: same as image 1, but lateral projection.These images do not explain why the coil did not detach or why it unraveled.The reported complaint is confirmed.Two radiographic images were provided for review.They are not labeled as to time or date.Both are unsubtracted single shots; however, it cannot be determined where the aneurysm that is being treated is.The event description does not specify the aneurysm location.From the wire and catheter position, it is assumed the aneurysm is an acom.The review of the images is as follows: p25-1720 image 1: ap unsubtracted single-shot radiograph, no contrast.There is an atlas stent spanning from the left a2 to the left a1.A microcatheter is seen with its tip in a medium-sized acom aneurysm.A loose coil mass is seen in the aneurysm.A coil has been partially deployed, and its proximal portion is seen, intact, inside the microcatheter, to the level of the distal supraclinoid ica; proximal to that, the coil is stretched, unraveled.The proximal end of the unraveled coil is not included on the radiograph.P25-1720 image 2: same as image 1, but lateral projection.These images show the coil is unraveled as described in the reported event; however, they do not explain why the coil did not detach or why it unraveled.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.
Event or Problem Description
See h11.

• Brand Name: HYDROFRAME-10-AV
• Common Device Name: DEVICE NEUROVASCULAR 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: 21655846
• Report Number: 2032493-2025-00237
• Device Sequence Number: 9402061
• Product Code: HCG
• UDI-Device Identifier: 00816777023599
• UDI-Public: (01)00816777023599(11)230928(17)280831(10)0000433125
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K090357
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

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: 100833HFRM-V-A2
• Device Lot Number: 0000433125
• 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: 03/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown