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

Model Number	45-780620-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	05/24/2021
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 has not yet been returned to the manufacturer for analysis.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 during treatment of an aneurysm, the embolization coil implant encountered resistance during insertion and advancing into the microcatheter and unexpectedly detached in the microcatheter.The coil and microcatheter were removed successfully from the patient and other coils of the same type were used to successfully complete the procedure.There was no reported patient injury or intervention.Patient reported to be "stable." this is report 1 of 4.Reference mfr.Reports#: 2032493-2021-00247, 2032493-2021-00248, and 2032493-2021-00249.
Additional Manufacturer Narrative
The investigation of the returned coil system found the implant stretched at proximal and to be attached to the pusher.No signs of activation was found on the pusher's heater coil and the introducer sheath was returned with dry blood contamination; furthermore, the device was experiencing heavy resistance/friction during functional testing using a compatible lab provided introducer sheath and microcatheter which is consistent with the damages found on the device.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 CX 18D-LONGER
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12037678
• Report Number: 2032493-2021-00246
• Device Sequence Number: 4000083
• Product Code: KRD
• UDI-Device Identifier: 00810170018312
• UDI-Public: (01)00810170018312(11)200729(17)250630(10)2007295ZA
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K123384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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: 06/30/2025
• Device Model Number: 45-780620-L
• Device Catalogue Number: 45-780620
• Device Lot Number: 2007295ZA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2021
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 06/26/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1