MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX DETACHABLE; EMBOLIZATION COIL

Model Number	45-781032
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history record indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The coil remains implanted in the patient and the remainder of the device was discarded at the user facility; therefore, a product evaluation could not be performed.The root cause is unknown.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during an embolization procedure, a previously implanted stent strut overlapped the neck of the aneurysm, which prevented the delivery of a 2f catheter.A 1.5 mm balloon and a 2 mm balloon were used to dilate the struts.Continued resistance was encountered while attempting to advance the catheter.A new catheter was used, which was able to advance.Resistance was encountered during the attempt to place the coil, and the coil detached from the pusher wire.A 3 cc syringe with saline was used to flush the detached coil into the intended treatment area.During an attempt to pull the catheter back slightly, the catheter position was lost in the aneurysm into the left anterior descending (lad) artery, and part of the coil was noted to remain there.The catheter was pulled into the guide and a stent was used to pin the coil against the proximal lad and into the left medial.The coil was left implanted in the ascending aorta.There was no reported patient injury.The patient was reported to be stable.

• Brand Name: AZUR CX DETACHABLE
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7686307
• Report Number: 2032493-2018-00139
• Device Sequence Number: 19182059
• Product Code: KRD
• UDI-Device Identifier: 00810170018350
• UDI-Public: (01)00810170018350(11)180305(17)230228(10)1803055W3
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K123384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2018

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: Other
• Device Expiration Date: 02/28/2023
• Device Model Number: 45-781032
• Device Catalogue Number: 45-781032
• Device Lot Number: 1803055W3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 07/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 76