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

Model Number	45-480410-L
Medical Device Problem Codes	Detachment Of Device Component (1104); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/18/2016
Type of Reportable Event	Malfunction
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; however, the pusher wire was returned for evaluation.The v-grip and microcatheter used for the procedure were not returned; therefore, analysis of the v-grip, microcatheter, and functional testing could not be performed.The pusher body coils showed no signs of damage.The pet over the heater coil had no visible signs of thermal cycling.The distal end of the monofilament was necked and a tail at the distal section.The electrical circuit was intact.The solder joints were intact at both the distal and proximal ends.Resistance was measured to be within specifications.Results of the product evaluation confirmed the coil was broken.The attachment tether was broken resulting in the implant unexpectedly detaching.The detachment monofilament had similar characteristics to that observed during tensile break, which is consistent with the monofilament being subjected to a force exceeding its tensile strength.Based on the reported procedure details and the product evaluation, the complaint of the coil break can be confirmed; however, the root cause cannot be determined.
Event or Problem Description
It was reported that after placement of an embolization coil in an aneurysm located at the lower polar splenic branch, resistance and friction were encountered within the microcatheter.During an attempt to reposition, the coil unexpectedly detached.There was no reported intervention.The coil remains implanted in the aneurysm.There was no reported patient injury.

• Brand Name: AZUR 18 PERIPHERAL V-TRAK SYSTEM
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6568832
• Report Number: 2032493-2017-00115
• Device Sequence Number: 905273
• Product Code: KRD
• UDI-Device Identifier: 00810170017902
• UDI-Public: (01)00810170017902(11)160614(17)210614(10)160614LC2
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K120630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/14/2017

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: Physician
• Device Expiration Date: 06/14/2021
• Device Model Number: 45-480410-L
• Device Lot Number: 160614LC2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2017
• Initial Report FDA Received Date: 05/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1