MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 35 HYDROCOIL DETACHABLE 10MM X 20CM; VASCULAR EMBOLIZATION DEVICE

Model Number	45-451020
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/11/2020
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 analysis.The investigation is currently underway.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.
Event or Problem Description
It was reported that coil embolization was performed in an internal iliac artery.During delivery of the 8th coil, the first 2-3 loops formed without issue, but advancing the coil became more difficult.The catheter was manipulated and the coil was re-advanced several times over the span of approximately 4.5 minutes until the coil would no longer advance.During the withdrawal attempt, the coil detached in the catheter.Both segments of the coil were removed together with the catheter without incident.The same catheter was reinserted and used to successfully deploy 3 more coils to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
The implant was returned for analysis.The pusher, introducer, and microcatheter were not returned for analysis.The implant was found to have a damaged monofilament with a profile indicative of a tensile break.The distal ball of the implant was found to be in good condition.Further investigation could not be completed, as the pusher or microcatheter were not returned for analysis.The inspection of the implant found the attachment monofilament to have a separation profile that is consistent with tensile force rather than thermal detachment from using a detachment controller.The event as described in the complaint description states that the coil was attempted to be repositioned over the span of 4.5 minutes, at which point the coil became stuck; the ifu for this product indicates a 3 minute repositioning time.The complaint is consistent with the implant's gel expanding to the point that the coil would not be able to move freely within the microcatheter.This would result in the implant separating from the pusher due to the implant becoming stuck and then having a retraction force placed upon it that exceeded the strength of the attachment monofilament.

• Brand Name: AZUR 35 HYDROCOIL DETACHABLE 10MM X 20CM
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 9832967
• Report Number: 2032493-2020-00064
• Device Sequence Number: 19565496
• Product Code: KRD
• UDI-Device Identifier: 00810170014970
• UDI-Public: (01)00810170014970(11)190104(17)231231(10)19010453F
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K093002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

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: 12/31/2023
• Device Model Number: 45-451020
• Device Catalogue Number: 45-451020
• Device Lot Number: 19010453F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 03/14/2020
• Supplement Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR