MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 18 HYDROCOIL DETACHABLE 6MM X 15CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	45-480615-L
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2020
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 was not returned to the manufacturer for evaluation.The root cause cannot be determined.The instructions for use (ifu) identifies difficult or premature coil detachment and coil migration or misplacement as potential complications associated with use of the device.
Event or Problem Description
It was reported that after placement of an embolization coil in a fistula, the coil would not detach after three attempts and the use of two different controllers.As the coil was being removed, it became lodged in the catheter and during the attempt to remove the coil and catheter together, the coil detached and migrated to the right ventricle and then to the pulmonary artery.The detached coil was snared from the patient in a subsequent procedure.There was no reported sequelae.The patient is reported to have recovered.

• Brand Name: AZUR 18 HYDROCOIL DETACHABLE 6MM X 15CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 10457761
• Report Number: 2032493-2020-00233
• Device Sequence Number: 4093185
• Product Code: HCG
• UDI-Device Identifier: 00810170017940
• UDI-Public: (01)00810170017940(11)180514(17)230430(10)18051454E
• Combination Product (Y/N): N
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/29/2020

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: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 45-480615-L
• Device Catalogue Number: 45-480615
• Device Lot Number: 18051454E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 08/26/2020
• 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