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

Model Number 45-751632

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/27/2021

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 not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If it is received at a later date, an investigation will be conducted and a supplemental report will be filed.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.

Event Description

It was reported that the physician was performing an ovarian vein embolization and when an embolization coil implant was being removed from its packaging, it was noticed that the delivery pusher was already kinked.The pusher was straightened and used.The implant detached from the delivery pusher in the microcatheter.There was no reported pateint injury or intervention.

Manufacturer Narrative

The investigation of the returned coil system found the implant stretched at proximal and to be separated from the pusher.No indication using a detachment controller was found on the pusher's heater coil.The investigation found the pusher's monofilament with a stretched tail/tensile break shape at the tip which is consistent with the device experiencing excessive force that exceeded the strength of the monofilament causing the implant to separate from the pusher.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: AZUR 35 CX 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: 12929990
• MDR Text Key: 286851254
• Report Number: 2032493-2021-00474
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00812636021096
• UDI-Public: (01)00812636021096(11)191002(17)240930(10)1910025J2
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/05/2021

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: 45-751632
• Device Catalogue Number: 45-751632
• Device Lot Number: 1910025J2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 12/14/2021
• Supplement Dates FDA Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2019
• 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 Age: 20 YR
• Patient Sex: Female