MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 18 CX DETACHABLE; VASCULAR EMBOLIZATION DEVICE

Model Number	45-780204-L
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	10/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device has not been returned to the manufacturer for evaluation.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 coil embolization of a right renal artery, the embolization coil did not advance, and then detached in the catheter as it was being withdrawn.The coil was removed together with the catheter.There was no reported patient injury, or additional intervention.
Additional Manufacturer Narrative
The microcatheter and coil implant were received for evaluation.The delivery pusher was not returned.No damage was found on the microcatheter.The implant was noted to be stuck inside the microcatheter and was damaged/stretched.The marker band and proximal glue bond section were bent and out of specification, which created an oversized effective diameter and would cause increased friction during advancement or retraction.The detachment of the implant is consistent with the implant becoming stuck and then experiencing retraction forces that exceeded the strength of the monofilament.

• Brand Name: AZUR 18 CX DETACHABLE
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 10813537
• Report Number: 2032493-2020-00326
• Device Sequence Number: 3500636
• Product Code: KRD
• UDI-Device Identifier: 00816777024374
• UDI-Public: (01)00816777024374(11)200512(17)250430(10)2005125Z8
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K162524
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2021

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: Other
• Device Expiration Date: 04/30/2025
• Device Model Number: 45-780204-L
• Device Lot Number: 2005125Z8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Initial Date Received by Manufacturer: 10/10/2020
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 02/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 80