MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 35 HYDROCOIL DETACHABLE 20MM X 30CM; VASCULAR EMBOLIZATION DEVICE

Model Number	45-452030
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2020
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 microcatheter and implant were not returned.No remnants of the implant were still attached.The introducer was found to be in good condition and without damage.Folding was noted at the distal strain relief of the delivery pusher.Additionally, there was a kink in the pusher just distal to the introducer tubing on the pusher.An supplied image from the field displays only the pusher with no implant present as well.The complaint indicated that part of the implant was still attached to the pusher; the customer supplied image and the physical evaluation of the returned device did not find any part of the implant to be attached to the pusher.The implant was not returned.The inspection of the heater coil section of the pusher found no evidence of activation using a detachment controller.The investigation could not confirm the condition or circumstances that led to the separation of the implant, but it is consistent with the implant experiencing tensile forces that exceeded the strength of the attachment monofilament.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 treatment was performed for a type 1 endoleak.After placement of 5 embolization coils, the 6th coil unexpectedly detached during repositioning.There was no reported patient injury or additional intervention.
Additional Manufacturer Narrative
Additional / clarifying information was received on (b)(6) 2020, which confirmed that the implant coil detached entirely within the target treatment site and remains implanted in the patient.

• Brand Name: AZUR 35 HYDROCOIL DETACHABLE 20MM X 30CM
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 9855677
• Report Number: 2032493-2020-00065
• Device Sequence Number: 16797184
• Product Code: KRD
• UDI-Device Identifier: 00810170015045
• UDI-Public: (01)00810170015045(11)190909(17)240831(10)1909095KG
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/18/2020

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: 08/31/2024
• Device Model Number: 45-452030
• Device Catalogue Number: 45-452030
• Device Lot Number: 1909095KG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1