MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX35 PERIPHERAL COIL SYSTEM; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number 45-750617

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/04/2021

Event Type  Injury  

Event Description

The last of the azur coils resulted in mal-deployment with the delivery wire prematurely releasing the coil and the inner portion of the pushing delivery wire was stretched.After deliberation, the decision was made to gently release the delivery wire and leave it in place.The proximal end of the delivery wire is located in the right common iliac artery and the distal end remains attached to the coil in the common hepatic artery.The last turn of the azur coil herniated into the proper hepatic artery but does not appear to result in any occlusion of the vessel.Maldevelopment of the final coil resulting in the delivery wire left in place extending from the common hepatic artery to the right common iliac artery without evidence of any undesired vascular occlusion or other injury.

• Brand Name: AZUR CX35 PERIPHERAL COIL SYSTEM
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICROVENTION, INC.; tustin CA 92780
• MDR Report Key: 12377175
• MDR Text Key: 268716630
• Report Number: MW5103527
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00812636021041
• UDI-Public: (01)00812636021041
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 45-750617
• Device Catalogue Number: 45-750617
• Device Lot Number: 2102155J2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 72