MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX 35 DETACHABLE; PERIPHERAL

Model Number MV-AX51019CD

Device Problem Difficult to Remove (1528)

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

Event Date 03/01/2023

Event Type  Injury  

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 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 mdr report.

Event Description

It was reported that during coil embolization of a portal vein, during manipulation of the coil the fluoroscopic image was not displayed, causing the pusher to be advanced too far due to no fluoroscopic confirmation.The implant was attempted to be detached however, unsuccessful.The coil system was caught in the liver and became unable to be removed.The pusher was then pulled but, the implant was neither detached nor stretched.Therefore, the pusher section was cut off outside the patient¿s body while being pulled.Cone-bean ct confirmed that the proximal end of the implant was completely entered into the patient¿s body, and the procedure was completed.Since the portal vein embolization was performed as a preoperative procedure for liver resection surgery, it was determined that there would be no problem for the patient with follow-up observation only since the coil remained in the right lobe which was scheduled for resection three weeks later.Additional information received on 02mar2023 indicated: in this case, percutaneous transhepatic portal vein embolization was performed by inserting a sheath into the portal vein through a direct puncture of the liver under echography from the right side of the abdomen.The coil remained in the liver.The pusher was cut and only the implant remained within the patient.Additional information received on 08mar2023 indicated: no intervention was taken.Ct images showed presence of the end of the cut device near the intra-abdominal ribs out of the liver.The patient recovered and was temporarily discharged from the hospital and scheduled to have liver resection three weeks later, as originally planned.The patient was not in serious condition and recovered.

• Brand Name: AZUR CX 35 DETACHABLE
• Type of Device: PERIPHERAL
• 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: 16534944
• MDR Text Key: 311208752
• Report Number: 2032493-2023-00611
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 04987892062933
• UDI-Public: (01)04987892062933(11)221005(17)270930(10)0000269623
• Combination Product (y/n): N
• PMA/PMN Number: K151358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MV-AX51019CD
• Device Lot Number: 0000269623
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2022
• 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