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

Model Number 181652CS-V-A1-CN

Device Problem Component Missing (2306)

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

Event Date 02/20/2024

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.

Event Description

It was reported the cosmos embolization coil was used as the third coil in a stent assisted embolization of large 23.2mm x 21.0mm internal carotid aneurysm.After the pathway was established, the stent was partially released and the first two coils were successfully implanted.When the third 16x52 cosmos coil was implanted, it was found that there was no implant coil at the end of the pusher.The pusher was removed and replaced it with another cosmos 13x47 coil and the was case completed successfully.Reportedly, post-procedure examination revealed that the 16x52 coil was detached in the delivery sheath.

Manufacturer Narrative

Additional information: d10, h3, h6, h11 (device evaluation).Device evaluation: investigation findings: items returned for evaluation: pusher; implant; introducer.The visual analysis of the returned items found the pusher hypotube and lead wire broken at the distal section, and the implant loops deformed, but still attached to the pusher.The introducer was returned undamaged.The introducer distal tip was found to be within specification.Investigation conclusion: the investigation of the returned coil system found the pusher hypotube and lead wire broken at the distal section, and the implant loops deformed; however, the implant coils found to be attached to the pusher upon receipt.The broken condition of the pusher is consistent with the device experiencing excessive force that exceeded the device's tensile strength, resulting in the pusher breaking.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.

• Brand Name: COSMOS-18-AV
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• 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: 19021373
• MDR Text Key: 339150313
• Report Number: 2032493-2024-00263
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00812636026183
• UDI-Public: (01)00812636026183(11)230421(17)280331(10)0000353361
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/02/2024

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: 181652CS-V-A1-CN
• Device Lot Number: 0000353361
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2024
• 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