MAUDE Adverse Event Report: MICROVENTION INC. AZUR-18 DETACHABLE HYDRO; VASCULAR FOR PROMOTING EMBOLIZATION DEVICE

Model Number	45-480420-L
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
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 not returned to the manufacturer for evaluation.Videos were provided.The investigation is currently 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.
Event or Problem Description
As reported, an embolization implant coil was placed in the coil mass and detached unexpectedly.The detached coil was able to be implanted in the treatment site.The patient was not harmed.
Additional Manufacturer Narrative
Two procedure videos were provided for review.The first video is a 6-second dsa (subtracted, with contrast) ap of the right renal artery.Multiple aneurysms are seen, arising from two lower branches of the right renal artery.The quality of the angiogram is degraded by bowel motion artifacts.The second video is a 6 second dsa (non-subtracted, with contrast) ap of right renal artery.Radiopaque platinum coils have been placed in the two lower renal branches.There is minimal flow past the coils with opacification of, but stasis in the aneurysms.The videos provided did not show the premature detachment described in the reported event.Without the return and physical evaluation of the device, the investigation is unable to determine if a condition existed that would have caused or contributed to the reported event.
Event or Problem Description
See h.10.

• Brand Name: AZUR-18 DETACHABLE HYDRO
• Common Device Name: VASCULAR FOR PROMOTING EMBOLIZATION DEVICE
• 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: 17560983
• Report Number: 2032493-2023-00906
• Device Sequence Number: 14352520
• Product Code: KRD
• UDI-Device Identifier: 00810170017926
• UDI-Public: (01)00810170017926(11)210317(17)260228(10)2103175JB
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2023

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 Expiration Date: 02/28/2026
• Device Model Number: 45-480420-L
• Device Lot Number: 2103175JB
• 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: 07/31/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2021
• 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
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic