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

Model Number MV-AX51019CD

Device Problems Detachment of Device or Device Component (2907); Difficult or Delayed Separation (4044)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/19/2021

Event Type  malfunction  

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 implanted in the patient and not returned to the manufacturer for evaluation.A product evaluation could not be performed and the alleged product issue could not be confirmed.If the device or additional information is received, microvention, inc., will issue a supplemental mdr report.The instructions for use (ifu) identifies premature and difficult or delayed coil detachment as potential complications associated with use of the device.

Event Description

It was reported that an embolization coil implant would not detach once placed in the target artery.During removal, the implant detached unexpectedly and was left entirely within the treatment site.There was no reported patient injury or intervention.

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 implanted in the patient and not returned to the manufacturer for evaluation.A product evaluation could not be performed and the alleged product issue could not be confirmed.If the device or additional information is received, microvention, inc., will issue a supplemental mdr report.The instructions for use (ifu) identifies premature and difficult or delayed coil detachment as potential complications associated with use of the device.

Event Description

It was reported that an embolization coil implant would not detach once placed in the target artery.During removal, the implant detached unexpectedly and was left entirely within the treatment site.There was no reported patient injury or intervention.

• Brand Name: AZUR CX 35 DETACHABLE
• Type of Device: 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: 13014440
• MDR Text Key: 285239743
• Report Number: 2032493-2021-00500
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 04987892062933
• UDI-Public: (01)04987892062933(11)201110(17)251031(10)2011105K9
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2021

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
• Device Operator: Health Professional
• Device Model Number: MV-AX51019CD
• Device Lot Number: 2011105K9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2021
• Initial Date FDA Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1