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

Model Number MV-AX50617CD

Device Problems Difficult or Delayed Positioning (1157); Malposition of Device (2616); Difficult or Delayed Separation (4044)

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

Event Date 08/26/2022

Event Type  Injury  

Event Description

During a celiac artery root embolization, azur cx35 8mm/24cm and cx35 6mm/17cm coils were placed via the catheter inserted through the right femoral artery, and then the coil concerned was inserted; however, the coil was not positioned properly.The coil was attempted to be retracted for repositioning; however, was unable to be retracted as it became entangled with the coils already placed.The pusher was able to be pulled back, but the coil remained stuck.Fluoroscopic examination confirmed that the coil had stretched over several centimeters from the detachment point to the distal portion of the coil.The coil was pushed into the target site and detached.The pusher was successfully removed from the patient along with the catheter without further stretching the coil.The procedure was completed, although several centimeters of the stretched and un-stretched portion of the coil remained extended out of the target site.Four days post-implantation, a stent-graft was successfully placed to affix the coil to the vessel wall, and the second procedure was completed without problems.The initial purpose of this case was stent-graft placement, and the coiling procedure was a planned pre-procedure.No serious patient harm was reported.

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 remains implanted in the patient and not available for return to the manufacturer for analysis; therefore, a product analysis could not be conducted, and the reported issue cannot be confirmed.The instructions for use (ifu) identifies coil migration or misplacement, and premature or difficult coil detachment as potential complications associated with use of the device.

• 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; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15422985
• MDR Text Key: 299926561
• Report Number: 2032493-2022-00368
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 04987892062872
• UDI-Public: (01)04987892062872(11)191008(17)240930(10)1910085K9
• 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: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MV-AX50617CD
• Device Lot Number: 1910085K9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2019
• 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
• Patient Outcome(s): Required Intervention