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

Model Number	45-480420
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2018
Type of Reportable Event	Malfunction
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 has not been returned to the manufacturer.The root cause could not be determined.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 a coil embolization of a splenic artery, the coil was left in the artery for approximately three (3) minutes prior to making the decision to deploy.The coil continued to get sucked into the defect, so an attempt was made to remove the coil.During removal, the coil detached in the catheter.Both segments of the coil were removed in their entirety from the patient.There was no reported intervention or patient injury.The patient was reported to be fine.
Additional Manufacturer Narrative
The device was returned with the pusher and coil for analysis.The pusher was noted to be stuck inside the introducer.The implant was found detached from the pusher; the coil was noted to be stretched along its length, and had the presence of the tie-knot.The relief on the pusher (distal black pet) was noted to be damaged.The pusher was dissected to access the attachment tether monofilament for investigation.The rebound length of the monofilament was noted to be within specification; however, the shape indicated that the coil was detached from the pusher.Based upon the investigation findings and available information, the reported complaint can be confirmed.The coil was detached from the pusher.The root cause cannot be determined; however, the device exhibits evidence that it was subjected to tensile forces that exceeded its strength specifications.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.

• 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: 7666672
• Report Number: 2032493-2018-00126
• Device Sequence Number: 13713255
• Product Code: HCG
• UDI-Device Identifier: 00810170017926
• UDI-Public: (01)00810170017926(11)180314(17)230228(10)180314537
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2018

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: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 45-480420
• Device Catalogue Number: 45-480420
• Device Lot Number: 180314537
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/08/2018
• Supplement Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 07/06/2018
• Supplement Report FDA Received Date: 08/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1