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

Model Number	45-480415
Medical Device Problem Codes	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	12/18/2018
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 returned with the pusher and implant for analysis.The implant was returned detached from the pusher.The proximal portion of the implant was observed to be stretched, and the overcoil was damaged.A kink was observed near the middle of the implant.The heater coil was in good condition, and the strain relief was not burned, which indicates the heater coil was not activated for detachment.The monofilament was found broken with a stretched tail, and retracted into the pusher with blood contamination.The proximal portion of the pusher was undamaged, and the resistance measured within specification.The middle of the pusher contained approximately two inches of lead wire separation.Based on the investigation the complaint was able to be confirmed.The broken monofilament and stretched proximal coils suggests detachment by the implant experiencing over specification of force.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 coil detached in the proximal portion of the vessel.The coil was successfully retrieved with a snare device.There was no reported patient injury.The patient is reported to be stable.

• 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: 8255414
• Report Number: 2032493-2019-00009
• Device Sequence Number: 16714370
• Product Code: HCG
• UDI-Device Identifier: 00810170017919
• UDI-Public: (01)00810170017919(11)161019(17)210930(10)161019LC1
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K090168
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/19/2018

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: 09/30/2021
• Device Model Number: 45-480415
• Device Catalogue Number: 45-480415
• Device Lot Number: 161019LC1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 01/16/2019
• 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
• Patient Age: 19 YR
• Patient Weight: 71