MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX 18D-LONGER; VASCULAR EMBOLIZATION DEVICE

Model Number	45-780204-L
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with the reported 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 implanted in the patient and not returned to the manufacturer for analysis.Additionally, procedural or post procedural images were not provided.The alleged product issue could not be confirmed.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 an embolization coil implant detached prematurely in the microcatheter during a treatment for a pulmonary arteriovenous malformation.The coil was advanced out of the microcahteter and could not be recaptured.It was the first coil in the case and the physician was able to secure and stabilize the implant coil with other subsequent coils.The procedure was completed, but no ability to readjust the coil.The patient is "stable".There was no patient injury nor medical or surgical intervention required.

• Brand Name: AZUR CX 18D-LONGER
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12340515
• Report Number: 2032493-2021-00335
• Device Sequence Number: 3938753
• Product Code: KRD
• UDI-Device Identifier: 00816777024374
• UDI-Public: (01)00816777024374(11)200907(17)250831(10)2009075Z8
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K123384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2021

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: 08/31/2025
• Device Model Number: 45-780204-L
• Device Lot Number: 2009075Z8
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1