MAUDE Adverse Event Report: MICROVENTION, INC AZUR-18 DETACHABLE HYDRO; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number 45-480202-L

Device Problem Premature Separation (4045)

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

Event Date 03/12/2024

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformances associated with the reported part and lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was reported available for return for analysis, but has not yet been received and procedure images not provided.Therefore, the alleged product issue cannot be confirmed at this time.If the device or additional information is received, a supplemental report will be submitted.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.

Event Description

It was reported that the azur 18 detachable embolization coil was used to treat a left iliolumbar artery.While manipulating the azur 18 coil, the physician inadvertently pulled back into the microcatheter an azur cx 18 coil that had been previously detached.Reportedly, the azur18 was unintentionally detached in the microcatheter and multiple attempts with various wires to push both coils out were unsuccessful.The microcatheter and azur 18 coil were removed from the patient along with the azur cx 18 that was still in the distal end of the microcatheter.No additional intervention was needed as much time had passed while attempting to correct the situation that the artery occluded with the first coil left in.There was no report of harm or injury to the patient.

Manufacturer Narrative

No additional information has been received.Device evaluation: investigation findings: items returned for evaluation: implant, progreat microcatheter.Items not returned for evaluation: pusher, introducer, shrink lock, dispenser hoop, microcatheter, v-grip.The visual analysis of the returned items found the implant in a separate bag with damaged coil and separated from the pusher.Further inspection found another implant to be separated from the pusher and stuck within the distal end of the microcatheter.The pusher was not returned for evaluation.The microcatheter was returned without observable kinks or damage, but it appeared wrinkled at the distal end.The implant was extracted from the microcatheter using an in-house mandrel.Inspection of the implant found to be deformed with blood residue on the coils.Further investigation found the implant's monofilament broken, indicating that the device experienced a tensile break.Investigation conclusion: the investigation of the returned coil system found the implant deformed, separated from the pusher and stuck within the distal end of the microcatheter.The pusher was not returned for evaluation.The investigation found that the implant's monofilament at the tie knot showed a 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 stretched implant but stretching is consistent with the device experiencing retraction forces over specification.

• Brand Name: AZUR-18 DETACHABLE HYDRO
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise; aliso viejo CA
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 18981190
• MDR Text Key: 338671152
• Report Number: 2032493-2024-00244
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00810170017841
• UDI-Public: (01)00810170017841(11)230808(17)280731(10)0000405679
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090168
• 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
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 45-480202-L
• Device Lot Number: 0000405679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2023
• 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
• Treatment: AZUR CX 35 DETACHABLE COIL; PROGREAT MICROCATHETER
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 74 KG