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

Model Number 45-752039

Device Problems Stretched (1601); Difficult or Delayed Separation (4044); Premature Separation (4045)

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

Event Date 06/03/2022

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be verified.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.A search for non-conformances associated with this part/lot number combinations did not reveal any production-related issues relevant to the complaints that occurred during manufacturing of the devices.

Event Description

It was reported that during splenic artery aneurysm embolization, the coil was attempted to be detached multiple times unsuccessfully.Upon withdraw, the coil stretched and unexpectedly broke.Segments of the broken coil remained within the splenic artery, and aneurysm.The inflow vessel proximal to the aneurysm was shut down by placing coils.During a final run, the vessel proximal to aneurysm arising off splenic artery was still patent.Patient recovery was uneventful.

• 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: 14702933
• MDR Text Key: 294139594
• Report Number: 2032493-2022-00232
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00812636021102
• UDI-Public: (01)00812636021102(11)211006(17)260930(10)0000097577
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 45-752039
• Device Catalogue Number: 45-752039
• Device Lot Number: 0000097577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2021
• 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
• Patient Age: 52 YR
• Patient Sex: Female