MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX 18D-LONGER; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	45-781836-L
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
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 component was stated to be available for return to the manufacturer for evaluation but has not yet been received.The alleged detachment after non detachment and incident 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.
Event or Problem Description
As reported: a patient who, prior to abdominal stent graft implantation, undergoes coil embolization of the right internal iliac artery.The vessel had no lesions; it simply needed to be occluded prior to stent implantation.A puncture is made in the right femoral artery using a 5f introducer; a cobra 2 catheter is advanced to catheterize the artery, and a second coil of the same size is then placed.Next, an 18 mm × 36 cm azur cx18 coil is placed, which does not release easily but eventually detaches on its own, remains implanted.Another coil of the same size is placed which, after multiple attempts and a change of release mechanism, cannot be implanted; therefore, it has been decided to withdraw it.There was no patient impact or injury.There was no medical or surgical intervention reported.Although requested, no additional clarification has been received.This report captures the issue with the coil that "detached on its own" and remains implanted.
Event or Problem Description
Although requested, to date, no clarification has been provided and the device was not received.
Additional Manufacturer Narrative
Procedure/medical information review: imaging review a single radiographic image is supplied.It is not labeled as to time or date.(b)(6) reporter provided image coil azur 18x36_(b)(6) collimated, magnified single shot radiograph of the pelvis centered over the right sacral wing.A diagnostic catheter is seen in the right common and external iliac arteries.Multiple platinum coils are seen in the proximal segment of the right internal iliac artery.Investigation findings: 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/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.¿ if a coil must be retrieved from the vasculature after detachment, do not attempt to withdraw the coil with a retrieval device, such as a snare, into the delivery catheter.This could damage the coil and result in device separation.Remove the coil, microcatheter, and any retrieval device from the vasculature simultaneously.Detachment of the coil: 34.When the azur detachment controller is properly connected to the 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 azur detachment controller.36.Push the detachment button.When the button is pushed, an audible tone will sound and the light will flash green.37.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 azur detachment controller attached to the delivery pusher and attempt another detachment cycle when the light turns green.38.The light will turn red after the number of detachment cycles specified on the azur detachment controller labeling.Do not use the azur detachment controller if the light is red.Discard the azur detachment controller and replace it with a new one when the light is red.39.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.Investigation conclusion: one radiographic image was provided for review.It is a magnified single shot radiograph of the pelvis, centered over the right sacral wing.A diagnostic catheter is seen in the right common and external iliac arteries.Multiple platinum coils are seen in the proximal segment of the right internal iliac artery.The provided image does not explain why the coil reportedly failed detach and then spontaneously detached.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.

• Brand Name: AZUR CX 18D-LONGER
• 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: 24804339
• Report Number: 2032493-2026-00230
• Device Sequence Number: 10679294
• Product Code: KRD
• UDI-Device Identifier: 00810170018398
• UDI-Public: (01)00810170018398(11)240309(17)290228(10)0000545777
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K123384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2026

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: 45-781836-L
• Device Lot Number: 0000545777
• 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: 03/17/2026
• Supplement Date Received by Manufacturer: 04/23/2026; 07/02/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 04/29/2026; 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2024
• 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: 5F INTRODUCER, DETAILS UNKNOWN.; COBRA 2 CATHETER, DETAILS UNKNOWN.; DETACHMENT CONTROLLER, QTY (B)(4), DETAILS UNKNOWN.
• Patient Sex: Unknown