MAUDE Adverse Event Report: MICROVENTION, INC. COSMOS-18-AV; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number 181243CS-V-A2

Device Problem Component Missing (2306)

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

Event Date 10/13/2022

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 reported to be available for return to the manufacturer for evaluation, but has not yet been returned.The reported missing coil could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.

Event Description

It was reported that after performing a balloon occlusion test for a patient with a brain tumor, the treatment plan would be to sacrifice the right internal carotid artery (ica).During the embolization treatment, challenges were encountered after insertion of the coil in the microcatheter and was noted that there was no coil visible under fluoroscopy.The pusher was removed from the microcatheter, and there was no coil found; the coil was missing.The right ica was sacrificed successfully by using seven (7) other coils, and the patient was reported to be doing okay.

Manufacturer Narrative

The investigation of the returned coil system found the pusher returned with no implant attached, and the body coil stretched and broken with the lead wires exposed at transition area.The implant was reported missing in the event; however, the build record for this lot number indicates the device had the implant attached to the pusher and met the specification prior to releasing the packaged device.Since the pusher's heater coil showed signs of activation using a detachment controller, and the pusher's monofilament showed a mushroom profile shape at the tip, this indicates that the implant was successfully detached from thermal activation using a detachment controller.The investigation of the returned device did not find any damage or other anomaly that would have caused or contributed to the reported complaint.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.

Event Description

Please see h10 for investigation conclusion.

• Brand Name: COSMOS-18-AV
• Type of Device: NEUROVASCULAR 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: 15777321
• MDR Text Key: 307769320
• Report Number: 2032493-2022-00520
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 181243CS-V-A2
• Device Lot Number: 2103015W1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• 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 Age: 65 YR