MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 35 FRAMER DETACHABLE; VASCULAR EMBOLIZATION DEVICE

Model Number	45-651434
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	05/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformance 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 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 treatment of an aneurysm, an embolization coil implant unexpectedly detached in the microcatheter.The coil, together with the catheter, were removed from the patient.There was no reported patient injury or additional intervention.
Additional Manufacturer Narrative
The investigation of the returned coil system found the implant stretched at proximal and separated from the pusher.No indication using a detachment controller was found on the pusher's heater coil.The investigation found the pusher's monofilament with a tensile break shape at the tip near the distal heater coil, which is consistent with the device experiencing excessive force that exceeded the strength of the monofilament causing the implant to separate from the pusher.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 35 FRAMER DETACHABLE
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11942552
• Report Number: 2032493-2021-00190
• Device Sequence Number: 19922708
• Product Code: KRD
• UDI-Device Identifier: 00810170016127
• UDI-Public: (01)00810170016127(11)201123(17)251031(10)2011235K8
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K111307
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2021

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: 10/31/2025
• Device Model Number: 45-651434
• Device Catalogue Number: 45-651434
• Device Lot Number: 2011235K8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1