MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 18 FRAMER DETACHABLE 20MM X 50CM; ARTIFICIAL EMBOLIZATION DEVICE

Model Number	45-682050-L
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	08/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformance 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 analysis; therefore, the alleged product issue cannot 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 treatment was performed for a splenic artery aneurysm.The embolization coil formed as intended in the aneurysm and was deployed.After deployment, it appeared that the coil appeared to be "fused" at the distal tip of the microcatheter.The microcatheter was manipulated to manually free the coil, but the coil would not release from the tip and it could not be pushed out.During an attempt to remove the microcatheter and coil together, the coil detached in the guide catheter and became unwound and left behind in the splenic artery and aorta.Multiple attempts were made to retrieve the coil with a snare device.The splenic artery became perforated and the patient was taken to the or for surgical intervention.The patient's current condition is reported to be "stable.".
Additional Manufacturer Narrative
Additional information: (h6) the instructions for use (ifu) identifies vessel perforation as a potential complication associated with use of the device.

• Brand Name: AZUR 18 FRAMER DETACHABLE 20MM X 50CM
• Common Device Name: ARTIFICIAL EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 10525827
• Report Number: 2032493-2020-00251
• Device Sequence Number: 3222237
• Product Code: KRD
• UDI-Device Identifier: 00810170017834
• UDI-Public: (01)00810170017834(11)190404(17)240331(10)1904045K5
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K050954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2020

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: Other
• Device Expiration Date: 03/31/2024
• Device Model Number: 45-682050-L
• Device Catalogue Number: 45-682050
• Device Lot Number: 1904045K5
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 09/15/2020
• 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