MAUDE Adverse Event Report: MICROVENTION, INC. AZUR-35 DETACHABLE HYDRO; VASCULAR EMBOLIZATION DEVICE

Model Number	45-450620
Medical Device Problem Codes	Difficult to Remove (1528); Unraveled Material (1664); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was implanted in the patient and not returned to the manufacturer for evaluation.Procedural images were not provided for review; therefore, the alleged product issue cannot be confirmed.A search for non-conformances associated with the reported part/lot number combination did not reveal any production-relatedissues relevant to the complaint that occurred during manufacturing of the device.
Event or Problem Description
It was reported that during embolization of the gastroduodenal artery with an embolization coil implant, the coil did not detach.During attempted removal, the embolization coil unraveled and fractured, extending into the infrarenal abdominal aorta.Intraoperative consultation with vascular surgery was made, whom recommended that given the patient's underlying medical comorbidities and condition, further attempts at retrieval or repositioning of the embolization coil should be aborted.There was no reported patient injury or intervention.

• Brand Name: AZUR-35 DETACHABLE HYDRO
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11898274
• Report Number: 2032493-2021-00187
• Device Sequence Number: 19754445
• Product Code: KRD
• UDI-Device Identifier: 00810170014932
• UDI-Public: (01)00810170014932(11)200303(17)250228(10)2003035KG
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K093002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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: 02/28/2025
• Device Model Number: 45-450620
• Device Catalogue Number: 45-450620
• Device Lot Number: 2003035KG
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 86