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

Model Number	45-480415-L
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformance 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 returned to the manufacturer for analysis.The investigation is currently underway.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during a peripheral embolization procedure, the embolization coil detached inside the microcatheter.The coil and the microcatheter were removed.There was no reported patient injury or additional intervention.The patient's condition is reported to be "stable.".
Additional Manufacturer Narrative
The investigation of the returned coil system confirmed the implant coil was stretched and detached from the pusher.No evidence of activation using a detachment controller was found on the pusher's heater coil, and the monofilament had a non-mushroom profile, which is consistent with an implant coil detachment due to the application of tensile force.

• Brand Name: AZUR 18 HYDROCOIL DETACHABLE
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 10554171
• Report Number: 2032493-2020-00258
• Device Sequence Number: 2385875
• Product Code: KRD
• UDI-Device Identifier: 00810170017919
• UDI-Public: (01)00810170017919(11)190919(17)240831(10)1909195JB
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K090168
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2020

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: Other
• Device Expiration Date: 08/31/2024
• Device Model Number: 45-480415-L
• Device Catalogue Number: 45-480415
• Device Lot Number: 1909195JB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 110