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

Model Number	100933CSSR-V
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
Additional 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 returned to the manufacturer for analysis and the investigation is currently underway.A supplemental report will be submitted when the investigation has been completed.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during positioning and navigating the coil in the microcatheter during a cerebral aneurysm embolization procedure, there was a presence of a filament wire parallel to the pusher, and the coil detached.The coil was removed and replace with another coil.There was no reported patient injury, and the patient was reported to be doing great.
Event or Problem Description
Additional information reported that there was a "2nd thread / filament" parallel, as if it had been unraveled, and the coil was still attached to the pusher when completely removed from the patient.
Additional Manufacturer Narrative
Additional information reported in b5: additional information reported that there was a "2nd thread / filament" parallel, as if it had been unraveled, and the coil was still attached to the pusher when completely removed from the patient.The reported complaint is confirmed.The investigation of the returned coil system found the pusher with lead wire separation and the implant stretched, damaged, and separated from the pusher.No indication using a detachment controller was found on the pusher's heater coil.The investigation found the pusher's monofilament with a tensile break shape at the tip which is consistent with the device experiencing excessive 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 damage, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: MICROPLEX COSMOS 10
• Common Device Name: 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: 14846933
• Report Number: 2032493-2022-00234
• Device Sequence Number: 4794150
• Product Code: HCG
• UDI-Device Identifier: 00810170014154
• UDI-Public: (01)00810170014154(11)201118(17)251031(10)2011185RC
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: K082461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Model Number: 100933CSSR-V
• Device Catalogue Number: 100933CSSR-V
• Device Lot Number: 2011185RC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2022
• Supplement Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male