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

Model Number	45-750511
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Detachment of Device or Device Component (2907); Migration (4003)
Health Effect - Clinical Code	Vascular System (Circulation), Impaired (2572)
Date of Event	06/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device has not been returned to the manufacturer.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that treatment was performed on a lower arm fistula to embolize a collateral vessel that was stealing flow.An attempt was made to retract the coil into the catheter and reposition it after a few centimeters of the coil had been deployed; however, the coil detached from the pusher while the implant coil was still partially in the catheter.The coil then migrated outside the catheter into the fistula.Attempts to snare the detached coil were unsuccessful.A dialysis catheter was inserted as a temporary solution for dialysis, as the fistula was no longer viable and the vessels were too small for a stent graft placement.The final angiogram did not demonstrate clot; however, it was believed that the location of the detached coil would ensure that the fistula would clot over time and an upper arm fistula will eventually be created.

• Brand Name: AZUR CX DETACHABLE
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8832635
• Report Number: 2032493-2019-00179
• Device Sequence Number: 14142057
• Product Code: KRD
• UDI-Device Identifier: 00812636021027
• UDI-Public: (01)00812636021027(11)161128(17)211031(10)16112811
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K151358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/28/2019

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: 10/31/2021
• Device Model Number: 45-750511
• Device Catalogue Number: 45-750511
• Device Lot Number: 16112811
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 07/26/2019
• 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; Disability