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

Model Number	45-780724-L
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2017
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.The coil remains implanted and the delivery pusher wire was discarded at the user facility; therefore, a product analysis could not be performed.
Event or Problem Description
It was reported that an azur embolization coil was implanted in the splenic artery, and other coils (not mv) were implanted afterward.The deployment went well and the azur coil appeared to be uniformly shaped in the vessel; however, approximately 8 minutes after implantation, the coil migrated distally.There were no negative effects to the patient.

• Brand Name: AZUR CX DETACHABLE
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6342644
• Report Number: 2032493-2017-00040
• Device Sequence Number: 18839661
• Product Code: KRD
• UDI-Device Identifier: 00810170018367
• UDI-Public: (01)00810170018367(11)160525(17)210525(10)160525L4
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/20/2017

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: 05/24/2021
• Device Model Number: 45-780724-L
• Device Lot Number: 160526L4
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2017
• Initial Report FDA Received Date: 02/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1