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

Model Number	7110-0204-3D-A2
Medical Device Problem Codes	Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a coil embolization procedure, the coil was attempted to be implanted in the aneurysm shoulder.The coil migrated into the pca where it remains in the wrong area.A stent was implanted.The case was completed.The patient will receive no further treatment.The patient status was reported as no patient harm.The operative report was requested, but it was not provided.
Additional Manufacturer Narrative
This report addresses the second coil.The first coil is referenced under mfr report# 2032493-2024-00725.Investigation findings: without the return and physical evaluation of the device, the investigation cannot definitively determine if a condition existed that would have caused or contributed to the reported event.Without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.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.Based on a review of the device¿s risk documentation, the reported event did not indicate there were 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.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.
Additional Manufacturer Narrative
Additional patient demographic information is documented in section a, additional event information is documented in section b5, and additional product evaluation information is documented in h11.The facility was contacted to reconfirm if the device is available to be returned to the manufacturer for evaluation.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.This report addresses the second coil.The first coil is referenced under mfr report# 2032493-2024-00725 medical operative report review.A detailed medical review of the operative reported dated (b)(6) 2024, was performed on (b)(6) 2024.As reported, the patient underwent stent assisted coiling which was performed utilizing a 3mm x 32mm lvis evo which was utilized for the treatment of the multilobulated basilar artery summit aneurysm.Intraoperatively on (b)(6) 2024, a working angle for coil embolization was determined from the rotational angiogram.After a headway 17 was advanced across the neck of the aneurysm over syncro-2 microwire, a duo-156 microcatheter was then manipulated into the aneurysm over a 0.014" syncro-2 microwire a 3 mm x32 mm lvis evo stent was deployed from the right p1 to the basilar artery.On (b)(6) 2024, data reviewed indicates that non detachment of last 2x4 hydrosoft 3d coils occurred despite physician performing multiple attempts which resulted in spontaneous detachment and stretching, and a small loop of coil was displaced into the right p1 segment without limitation of flow reported.Multiple attempts to deploy second stent in y configuration resulted in stent being stuck inside the catheter (x2).Procedure was stopped and the treated aneurysm was reported as satisfactorily occluded.Based on the review of data and in my medical opinion, non-detachment of last 2x4 hydrosoft 3d coils occurred with spontaneous detachment and stretching reported.A small loop of coil was displaced into right p1 without flow limitation was reported.In addition, attempts to deploy a second stent in y configuration resulted in stent being stuck inside the catheter (x2) as reported.No device malfunction was reported within the operative report reviewed as causative association with the non-detachment 2x4 hydrosoft 3d coils and stretching which occurred with the coils.No device malfunction was reported within the operative report reviewed as causative association of the deploy second stent which resulted in the stent being stuck inside the catheter (x2).The patient was reported as doing ok post-operatively.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.
Event or Problem Description
The coil was not detaching appropriately in situ.The coil passed pretest with the detaching handle.Then, the coil was advanced into the aneurysm; detacher indicated by a beeping sound that the coil had been detached.The push wire was then pulled back into the catheter, and it was noted the coil was still attached and had not detached.The coil was attempted to be repositioned without success, and it was noticed that it had now detached in the catheter.
Additional Manufacturer Narrative
This follow up report is being submitted to notify of a correction to the previous report that the customer had submitted a medwatch report to the fda with the related mdr report # mw5160850.Please note: this information does not impact the data previously reported.
Event or Problem Description
See h11.

• 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: 20519131
• Report Number: 2032493-2024-00778
• Device Sequence Number: 7794110
• Product Code: KRD
• UDI-Device Identifier: 00816777025388
• UDI-Public: (01)00816777025388(11)231102(17)281031(10)0000455343
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K161367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 01/13/2025

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: 7110-0204-3D-A2
• Device Lot Number: 0000455343
• 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: 10/01/2024
• Supplement Date Received by Manufacturer: 11/07/2024; 01/13/2025
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 11/27/2024; 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2023
• 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
• Patient Age: 62 YR
• Patient Sex: Female