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

Model Number	45-481015-L
Medical Device Problem Codes	Unraveled Material (1664); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during embolization treatment of a left hepatic artery aneurysm, the coil was retracted and positioned without encountered resistance.The coil was report to have detached from the delivery pusher.Attempts were made to retract and advance the coil unsuccessfully.The majority of the coil remained within the microcatheter which was still positioned within the common hepatic artery and celiac trunk.The coil was snared within the 5fr base catheter via the micro catheter.The proximal portion of the coil was successfully snared, however only a small portion of the coil was retrieved on retraction.The main portion of the coil was deployed within the distal common hepatic artery and proximal common hepatic artery by injection of saline via the base catheter.As this was non-occlusive, the coil was left in situ.On removal of the base catheter it was reported that there remained a long attached, unraveled portion of coil extending back to the celiac axis, aorta and right common iliac artery.Patient is not showing symptoms from the mal-positioned coil at this time.No patient harm or injury was reported.No further treatment is planned to address the unraveled portion of the coil.
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 has not yet been returned to the manufacturer; therefore, a product evaluation could not be performed and the alleged product issue could not be confirmed.If the device or additional information is received, microvention, inc., will issue a supplemental mdr report.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
Additional Manufacturer Narrative
The pusher and introducer sheath were the only components received for evaluation.The investigation of the returned coil system found the implant to be separated from the pusher.No indication of using a detachment controller was found on the pusher's heater coil.The investigation found the pusher's monofilament with a tensile break shape at the tip, which is consistent with the device experiencing excessive 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 damage, but the damage is consistent with the device experiencing forces over specification.Imaging was provided that did show a mass of coils in the hepatic aneurysm with a gradually stretched coil running from the aneurysm to the hepatic artery with a thin filament seen in the visible portion of the abdominal aorta.

• Brand Name: AZUR-18 DETACHABLE HYDRO
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 13586635
• Report Number: 2032493-2022-00063
• Device Sequence Number: 5817723
• Product Code: HCG
• UDI-Device Identifier: 00810170018008
• UDI-Public: (01)00810170018008(11)170306(17)230831(10)18090451Z
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K050954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 45-481015-L
• Device Catalogue Number: 45-481015
• Device Lot Number: 18090451Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2018
• 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; Other
• Patient Sex: Male