MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 18 PERIPHERAL V-TRAK SYSTEM; EMBOLIZATION COIL

Model Number	45-480620
Medical Device Problem Codes	Difficult to Remove (1528); Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2018
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 device was not available to send to the manufacturer for analysis; 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 after placement of multiple embolization coils in a splenic aneurysm, the last coil came back with the catheter system during withdrawal.Contralateral access was obtained and the coil was retrieved with a snare.A post-procedure ct performed later that evening demonstrated a segment of the coil positioned over the aortic bifurcation with an end in each of the common iliac arteries.The following day, the patient returned for an additional procedure, in which the coil segment was successfully removed with a snare device.There was no patient injury as a result of the issue.The patient is reported to have made a full recovery and is fine now.

• Brand Name: AZUR 18 PERIPHERAL V-TRAK SYSTEM
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8187162
• Report Number: 2032493-2018-00273
• Device Sequence Number: 16518591
• Product Code: HCG
• UDI-Device Identifier: 00810170017957
• UDI-Public: (01)00810170017957(11)170817(17)220731(10)170817556
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K090168
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2018

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: 07/31/2022
• Device Model Number: 45-480620
• Device Catalogue Number: 45-480620
• Device Lot Number: 170817556
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/20/2018
• 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