MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX COSMOS 18 VTA; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number 180827CS-V-A2

Device Problems Separation Problem (4043); Premature Separation (4045)

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

Event Date 09/09/2021

Event Type  Injury  

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 investigation of the returned implant found the implant severely stretched & damaged with dry blood contamination.The damaged implant is indicative of the device experiencing retraction forces causing the implant to stretch; however, the investigation is unable to determine the cause of the non-detachment due to the missing pusher.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.

Event Description

It was reported that during an embolization treatment, the implant coil did not detach initially.A second detachment controller was tried; however, unsuccessful.Upon withdrawal of the device, the coil partially detached within the aneurysm.The coil was removed using a stent retriever successfully.There was no harm or injury to the patient, who was reported to be successfully treated.

• Brand Name: MICROPLEX COSMOS 18 VTA
• 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: 12593242
• MDR Text Key: 277751926
• Report Number: 2032493-2021-00403
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777022578
• UDI-Public: (01)00816777022578(11)210408(17)260331(10)2104085P1
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K093358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 180827CS-V-A2
• Device Lot Number: 2104085P1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2021
• 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 Outcome(s): Required Intervention