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

Model Number	45-780724
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records 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 analysis 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 the physician was attempting to coil the gastroduodendal artery (gda).The coil was forming nicely, but the microcatheter lost access to the vessel.The physician retracted the coil and was able to regain access to the vessel.An attempt was made to deploy the coil.The coil was deployed approximately 75% in the gda where it was supposed to be; however, the coil detached from the pusher wire and some of the coil was left hanging in the hepatic artery.Multiple attempts were made to remove the coil with a snare device, but were unsuccessful.The physician decided to deploy a covered stent in the hepatic artery to affix the remaining coil against the wall of the artery and the wall of the stent, which allowed the patient's artery to remain patent.There was no reported patient injury.

• 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: 8272811
• Report Number: 2032493-2019-00013
• Device Sequence Number: 19147228
• Product Code: KRD
• UDI-Device Identifier: 00810170018329
• UDI-Public: (01)00810170018329(11)180207(17)230131(10)1802075W3
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/24/2018

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: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 45-780724
• Device Catalogue Number: 45-780724
• Device Lot Number: 1802075W3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/24/2018
• Initial Report FDA Received Date: 01/23/2019
• 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