MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX 35 DETACHABLE; DEVICE VASCULAR FOR EMBOLIZATION

Model Number	45-752039
Medical Device Problem Codes	Stretched (1601); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The device was implanted in the patient and will not be returned to the manufacturer for evaluation.However, the pusher component of the device was returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.This report addresses the second coil.The first coil is referenced under mfr report #2032493-2025-90628.
Event or Problem Description
It was reported that during a splenic embolization procedure, two coils became elongated.The physician attempted to retrieve the coils; however, both of them prematurely detached.A wire was used to push the coils backed into the vessel.The procedure was completed successfully.The patient is doing well.
Additional Manufacturer Narrative
The investigation of the returned coil system found the pusher heater coil kinked, and the proximal section of the implant stretched, which is consistent with the coil elongation described in the reported event.The event description states that the coil was not retrieved and was pushed into the vessel, which would indicate that the coil was detached; however, the implant coil was returned still attached to the pusher.The physical evaluation of the device could not identify the conditions or circumstances that led to the kinked heater coil and the stretched implant, but the damage is consistent with the device experiencing forces exceeding the pusher and implant's yield strength.The catheter used in the procedure was not returned, so the investigation could not determine if it had caused or contributed to the reported complaint.Based on our investigation findings, there was no coil detachment malfunction.The coil was stretched.Therefore, mvi no longer considers this event a reportable malfunction event.
Event or Problem Description
See h11.

• Brand Name: AZUR CX 35 DETACHABLE
• Common Device Name: DEVICE VASCULAR FOR 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: 23503896
• Report Number: 2032493-2025-90639
• Device Sequence Number: 9048548
• Product Code: KRD
• UDI-Device Identifier: 00812636021102
• UDI-Public: (01)00812636021102(11)250328(17)300228(10)0001048288
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K151358
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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: 45-752039
• Device Lot Number: 0001048288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2025
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2025
• 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