MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 18 HYDROCOIL DETACHABLE 2MM X 2CM; VASCULAR EMBOLIZATION DEVICE

Model Number	45-480202-L
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2020
Type of Reportable Event	Malfunction
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 to the manufacturer for evaluation.The investigation is currently ongoing.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 placement in the treatment site, the coil would not take shape.During retraction of the device, the implant coil detached from the pusher wire.The implant coil was removed together with the microcatheter.There was no reported patient injury or additional intervention.The patient's condition is reported to be "stable.".
Additional Manufacturer Narrative
The pusher and implant were returned for evaluation.Investigation into the returned device found the implant not attached to the pusher.The implant was stretched and had broken overcoils, broken gel, and kinked implant coils.Inspection of the pusher found the strain relief burnt and the connector was found slightly bent.Additionally, the monofilament profile was found with a mushroom profile.Both the burnt strain relief and mushroom profile suggests that the coil was detached using the v-grip detachment controller.The investigation of the returned coil system found the implant separated from the pusher with signs of activation using the detachment controller.The implant was damaged, and as a result of the damage, the implant did not have the correct shape.The pusher was also kinked at the gold connector, though it is unlikely that this damage is related to the complaint as described.The physical evaluation of the returned coil could not determine the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.The microcatheter used in the procedure was not received for evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.

• Brand Name: AZUR 18 HYDROCOIL DETACHABLE 2MM X 2CM
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 10177045
• Report Number: 2032493-2020-00139
• Device Sequence Number: 3514625
• Product Code: KRD
• UDI-Device Identifier: 00810170017841
• UDI-Public: (01)00810170017841(11)191104(17)241031(10)1911045JB
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2020

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: Other
• Device Expiration Date: 10/31/2024
• Device Model Number: 45-480202-L
• Device Catalogue Number: 45-480202
• Device Lot Number: 1911045JB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1