MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 35 CX DETACHABLE 8MM X 12CM; EMBOLIZATION COIL

Model Number	45-750812
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Vascular System (Circulation), Impaired (2572)
Date of Event	10/23/2019
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 was returned with the pusher, dispenser hoop, and introducer for analysis.The implant was confirmed to not be attached and was also not returned.Since the implant was not attached, this limited the investigation of the device and complaint.Investigation into the returned components found the introducer to be in good condition and without damage.During the inspection of the returned pusher, the heater coil was found without burn marks, but the strain relief was found folded.The gold connector of the pusher was also found to be in good condition.Further inspection found that the resistance and continuity of the pusher were in specification.Inspection of the monofilament profile displayed damage indicating a tensile break.The heater coil was found without burn marks and the monofilament did not display a mushroom profile tip, indicating that the device was not detached by a controller.Furthermore, the strain relief was found folded in, indicating that the device was compressed.The investigation could not definitively determine the cause of the damage as the implant was not returned and the description of the complaint was not clear.However, it is suspected that the device was damaged during advancement and then detached during retraction.Based on the damage found on the pusher and the detached implant, this device indicates that it experienced excessive compressive and tensile forces.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that an embolization implant coil detached in the wrong location and protrudes into the patient's aorta.There was no reported intervention.

• Brand Name: AZUR 35 CX DETACHABLE 8MM X 12CM
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 9507667
• Report Number: 2032493-2019-00302
• Device Sequence Number: 1215577
• Product Code: KRD
• UDI-Device Identifier: 00812636021058
• UDI-Public: (01)00812636021058(11)180524(17)230430(10)18052454N
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 11/27/2019

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: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 45-750812
• Device Catalogue Number: 45-750812
• Device Lot Number: 18052454N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 12/20/2019
• 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: Disability