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

Model Number 181347CS-V-A1-CN

Device Problem Premature Separation (4045)

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

Event Date 01/18/2024

Event Type  malfunction  

Event Description

It was reported, renal artery segment aneurysm, 24 x 20 in size.The peripheral guide wire and microcatheter were in place, and the 20 x 50 and 20 x 50 coils were filled in.When pushing the third coil 13 x 47, the resistance of the coil in the microcatheter was high, and it could not be pushed forward.When retracting the coil, the coil broke in the microcatheter, causing both the microcatheter and the coil to be scrapped.After replaced the new microcatheter and coil, the procedure ended normally.There was no patient injury.It was reported that the status of the patient was normal.

Manufacturer Narrative

The device was stated to be available for return to the manufacturer for evaluation, but has not yet been returned.The alleged product issue/event as described 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.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.

Manufacturer Narrative

The investigation of the returned coil system found the pusher strain relief damaged, the pusher twisted at the attachment area, and the implant to be separated from the pusher.The microcatheter used in the procedure with the coil system was returned cut at 16cm from the proximal end of strain relief.Only the portion of the microcatheter proximal to the cut was returned for evaluation.No implant was found within the returned portion of the microcatheter.The investigation found the pusher¿s monofilament with a tensile break shape at the tip, which is consistent with the device experiencing 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 pusher damage, but the damage is consistent with the device experiencing forces over specification.As the microcatheter was returned cut and the distal section of the microcatheter was not returned for evaluation, this investigation could not determine if a condition existed on the microcatheter that would have caused or contributed to the reported complaint.

Event Description

No additional information received.

• 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: 18803775
• MDR Text Key: 336635250
• Report Number: 2032493-2024-00173
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 181347CS-V-A1-CN
• Device Lot Number: 0000350362
• 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: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2023
• 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
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 48 KG