MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 35 CX DETACHABLE 16MM X 32CM; VASCULAR EMBOLIZATION DEVICE

Model Number	45-751632
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	05/27/2020
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 not returned to the manufacturer for evaluation.The root cause cannot be determined.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 an embolization coil detached unexpectedly inside the catheter after only a small portion of the coil had exited the catheter.The coil was withdrawn from the patient together with the microcatheter.There was no reported patient injury or additional intervention.
Additional Manufacturer Narrative
The microcatheter used in the procedure was not returned for analysis.The device was received with the implant detached from the pusher.Inspection of the implant found the coil completely stretched from the proximal loop to the distal loop.The uv glue bonds on the device were found to have met specifications.The v-grip was returned with the device for evaluation and was found intact with no notable damage.The monofilament was removed from the pusher body coil and the tip was found to have a stretched tail shape.The implant was found separated from the pusher with no signs of activation using a detachment controller.The pusher's monofilament had a tail-like profile, indicating the separation of the implant was due to excessive tensile or retraction forces.The stretching of the implant coil is also indicative of said forces.The microcatheter used in the procedure was not evaluated as a part of this evaluation, it could not be determined if it had caused or contributed to the reported complaint.

• Brand Name: AZUR 35 CX DETACHABLE 16MM X 32CM
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 10201378
• Report Number: 2032493-2020-00149
• Device Sequence Number: 2234757
• Product Code: KRD
• UDI-Device Identifier: 00812636021096
• UDI-Public: (01)00812636021096(11)170928(17)220831(10)17092854L
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K151358
• 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): 05/28/2020

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: 08/31/2022
• Device Model Number: 45-751632
• Device Catalogue Number: 45-751632
• Device Lot Number: 17092854L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 08/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1