MAUDE Adverse Event Report: MICROVENTION, INC. AZUR-18 DETACH PLATINUM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	45-680820-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	03/22/2021
Type of Reportable Event	Serious Injury
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 was not returned to the manufacturer for evaluation.Additionally, procedural images were not provided; therefore, the reported event cannot be confirmed.
Event or Problem Description
It was reported that during an embolization procedure for a pseudo-aneurysm, the delivery pusher of an embolization coil implant separated into two pieces.The physician flushed the coil into position and attempted to snare the part of the pusher still inside of the patient.Part of the coil was removed successfully, however a portion remains within the patient.Additional fluoro time was needed to try to retrieve the coil.No patient injury was reported.
Additional Manufacturer Narrative
The investigation of the returned coil system found the implant completely stretched, broken, and to be separated from the pusher.The distal end of the implant was not returned for evaluation.No indication using a detachment controller was found on the pusher's heater coil.The investigation found the pusher's monofilament with a tensile break shape at the tip which is consistent with the device experiencing excessive force that exceeded the strength of the monofilament causing the implant to separate from the pusher.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: AZUR-18 DETACH PLATINUM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11691608
• Report Number: 2032493-2021-00146
• Device Sequence Number: 3121468
• Product Code: HCG
• UDI-Device Identifier: 00810170017742
• UDI-Public: (01)00810170017742(11)200210(17)250131(10)2002105J5
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K050954
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2021

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: 01/31/2025
• Device Model Number: 45-680820-L
• Device Catalogue Number: 45-680820
• Device Lot Number: 2002105J5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 06/11/2021
• 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