MAUDE Adverse Event Report: MICROVENTION, INC. COSMOS-10-AV; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number 100408CSSR-V-A2

Device Problems Break (1069); Separation Problem (4043)

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

Event Date 10/05/2021

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformances associated with the reported 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 returned to the manufacturer for analysis; howver, investigation is not complete and still ongoing.The instructions for use (ifu) identifies difficult coil detachment as potential complications associated with use of the device.

Event Description

It was reported that during an embolization treatment, the coil prematurely detached from the delivery pusher during deployment.The coil was reported to have not detached or broken in the intended target vessel; however, there were no clinical consequences for the patient.

Manufacturer Narrative

There is one supplied radiographic image: a lateral plain x-ray of the upper beck showing a short opaque platinum coil fragment.This image does not substantiate the complaint on its own however.The pusher and microcatheter were the only components received for evaluation.No damage was found on the returned microcatheter and no components were found inside the microcatheter after investigation under x-ray.The investigation of the returned coil system found the pusher severely stretched starting at the attachment bond and broken at the distal end.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-10-AV
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 13171228
• MDR Text Key: 287125030
• Report Number: 2032493-2022-00001
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777021687
• UDI-Public: (01)00816777021687(11)180609(17)230531(10)1806095Y2
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K082461
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 100408CSSR-V-A2
• Device Lot Number: 1806095Y2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2018
• 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