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

Model Number	45-751019
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	08/08/2022
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 analysis; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental report.The instructions for use (ifu) identifies premature coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that the first coil used started to unravel/stretch during pulling for repositioning.The coil was removed from the patient.The second coil deployed detached unintentionally during pulling for repositioning and coil got stuck in the microcatheter when attempted to manually push out.The entire coil was removed together with the microcatheter.Procedure outcome was successful and patient was stable.
Additional Manufacturer Narrative
Summary device evaluation: only the implant was returned for evaluation.Visual inspection of the implant found the proximal end to be severely stretched.The physical evaluation of the device could not determine the exact circumstances that led to this condition, but the stretching is indicative of the coil encountering resistance followed by retraction forces that exceeded the strength of the coil winding.The pusher was not returned for evaluation, so the investigation could not definitively determine the mode of separation (i.E.Thermal or tensile), nor could the physical evaluation determine when or where the separation occurred.The microcatheter used in the procedure was not returned, so the investigation could not determine if a condition existed that would have caused or contributed to the reported event.

• Brand Name: AZUR CX 35 DETACHABLE
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15283715
• Report Number: 2032493-2022-00323
• Device Sequence Number: 2504322
• Product Code: KRD
• UDI-Device Identifier: 00812636021072
• UDI-Public: (01)00812636021072(11)211202(17)261130(10)0000131359
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K151358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2022

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 Model Number: 45-751019
• Device Catalogue Number: 45-751019
• Device Lot Number: 0000131359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown