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

Model Number	45-752039
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.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.
Event or Problem Description
As reported: during a splenic embolization with left radial access a 105cm dss was placed into the splenic artery.Multiply coils were deployed into the outflow vessel (azur cx 035 6-10mm) successfully with the navi 135cm.When the 135cm navi was advanced into the 4.5cm aneurysm for coil embolization.When advancing the 20mmx39cm (lot#0001089719) coil into the aneurysm via the navi, the coil was pushing smoothy until it reached the tip of the navi.At this point when the doctor went to retract the coil it detached inside the navi.He tried to push the coil with a 035 wire but it would not advance all the way out into the aneurysm.He decided to pull the coil & navi out.The coil was removed successfully inside the navi.He wanted to open up another navi catheter to use for delivering the coils.Another 20mmx39cm coil was opened & this coil was deployed into the sac but the coil had a very hard time tracking.At this point we tried another 20mmx39mm coil (lot#0001101668) via the navi & this coil had trouble tracking & advancing through the navi tip.When the doctor went to retract the coil, it also detached.He had to remove the navi & coil.The coil was removed successfully at this point we decided to place the ravi mg1 catheter to possibly make the delivery of the coil better.This time we tried an azur 35 20mmx30cm (lot#0000395155) this coil would not tract very well & had trouble advancing through the ravi tip, the coil would not work so he the coil was removed intact.He tried a azur cx 035 16mmx39cm coil was advanced & placed into the sac.This coil had a little trouble but deployed successfully.We decided to try another azur cx 035 20mmx39cm(lot#0000783202) & this coil would not advance through the ravi into the sac.The coil was removed because it would not advance & he did not want it to detach.That coil was removed successfully.At this point it was decided to just take out the inflow vessel.This was accomplished using multiple azur cx 035 & azur 035 coils.The case finished successfully & the patient left the room in stable condition.
Additional Manufacturer Narrative
The investigation of the returned coil system found the implant coil stretched from the proximal to the distal section and separated from the pusher; however, no indications of activation using a detachment controller was found on the pusher heater coil.The investigation found the pusher's monofilament with a tensile break shape at the tip, which is consistent with the device experiencing force that exceeded the strength of the monofilament causing the implant to separate from the pusher.The physical evaluation of the device could not identify the conditions or circumstances that led to the stretched implant, but the damage is consistent with the device experiencing forces exceeding the 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.
Event or Problem Description
No new information was provided.

• Brand Name: AZUR CX 35 DETACHABLE
• 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: 23050661
• Report Number: 2032493-2025-90484
• Device Sequence Number: 18584166
• Product Code: KRD
• UDI-Device Identifier: 00812636021102
• UDI-Public: (01)00812636021102(11)250512(17)300430(10)0001089719
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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: 45-752039
• Device Lot Number: 0001089719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2025
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AZUR 035 COILS.; AZUR CX 035.; NAVI 135CM.
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic