MAUDE Adverse Event Report: MICROVENTION, INC. AZUR-18 DETACHABLE HYDRO; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number 45-482030-L

Device Problem Premature Separation (4045)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/12/2024

Event Type  Injury  

Event Description

It was reported that the embolization coils were used in a procedure to embolize a splenic artery aneurysm via brachial access.Following successful implantation of 3 coils, it was noted that the microcatheter could not be flushed.The catheter was removed from patient and it was found that the 4th coil had not detached.The coil was flushed out and removed from the catheter.Reportedly, when advancing the replacement 5th coil, it prematurely detached half in the coil pack and half in the catheter.The coil remained in situ when the microcatheter was removed.A balloon was inflated within destination sheath to secure the detached coil and the sheath and coil were then successfully removed.No additional coils were deemed necessary as the aneurysm had thrombosed.There was no adverse affect to the patient.

Manufacturer Narrative

Investigation summary: investigation findings: items returned: - n/a visual analysis: a visual inspection of the device captured in this file could not be performed as a physical device was not returned for evaluation, nor were any images of the device provided in place of a device return.Procedure and medical imaging was not provided for this investigation.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.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 and 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): please refer to the japanese ifu for precautions, warnings, and further information.The following is taken from the english version: potential complications potential complications include, but are not limited to: hematoma at the site of entry, vessel/aneurysm perforation, unintended parent artery occlusion, incomplete filling, vascular thrombosis, hemorrhage, ischemia, vasospasm, edema, coil migration or misplacement, premature or difficult coil detachment, clot formation, revascularization, post-embolization syndrome, and neurological deficits including stroke and possibly death.The physician should be aware of these complications and instruct patients when indicated.Appropriate patient management should be considered.Warnings and precautions ¿ this device is intended for single use only.Do not reuse, reprocess or resterilize.Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness, or death.Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another.Contamination of the device may lead to injury, illness or death of the patient.¿ advance and retract the azur system slowly and smoothly.Remove the entire azur system if excessive friction is noted.If excessive friction is noted with a second azur system, check the microcatheter for damage or kinking.¿ due to the delicate nature of the coils, the tortuous vascular pathways that lead to certain lesions, and the varying morphologies of the vasculature, a coil may occasionally stretch while being maneuvered.Stretching is a precursor to potential coil breakage and migration.¿ if repositioning is necessary, take special care to retract the coil under fluoroscopy in a one-to-one motion with the delivery pusher.If the coil does not move in a one-to-one motion with the delivery pusher, or if repositioning is difficult, the coil may have become stretched and could possibly break.Gently remove and discard the entire device.Introduction and deployment of the azur system 22.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.23.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.24.Push the azur system through the microcatheter until the proximal end of the 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 delivery pusher.Slide the introducer sheath completely off of the delivery pusher.Use care not to kink the delivery system.To prevent premature hydration of the azur system, ensure that there is flow from the saline flush.27.Under fluoroscopic guidance, slowly advance the coil out the tip of the microcatheter.Continue to advance the 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 delivery pusher during or after delivery of the coil into the vasculature.Rotating the delivery pusher may result in a stretched coil or premature detachment of the coil from the 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 undesired vasculature.28.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.Investigation conclusion: the physical device was not available for evaluation to determine if a condition existed that would have caused or 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 definitively determine the cause of the reported event.This information may be updated if additional information is provided at a later date.

• Brand Name: AZUR-18 DETACHABLE HYDRO
• Type of Device: 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: 18789312
• MDR Text Key: 336344348
• Report Number: 2032493-2024-00166
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K090168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2024

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
• Device Operator: Health Professional
• Device Model Number: 45-482030-L
• Device Lot Number: 0000456006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AZUR-18 DETACHABLE HYDRO COIL; GLIDECATH CATHETER; PROGREAT MICROCATHETER
• Patient Outcome(s): Required Intervention