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

Model Number	182468CS-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	09/18/2021
Type of Reportable Event	Malfunction
Additional 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 implant coil was returned to the manufacturer for analysis and evaluation is underway.The instructions for use (ifu) identifies stent thrombosis as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during an aneurysm embolization procedure, the pusher detached in the microcatheter.The devices were successfully removed from the patient and a new set was used to completed the case.There was no harm or injury to the patient.
Additional Manufacturer Narrative
Summary of device evaluation: the reported complaint is unconfirmed.The microcatheter used in the procedure was not evaluated as a part of this evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.The reported complaint stated the pusher was detached/broken during the procedure; however, the investigation of the returned coil system found the pusher's body coil damaged near the attachment bond with no signs of fracture or breakage on the body coil.The implant was found deformed and to be separated from the pusher with no signs of activation on the distal heater coil.The investigation found the pusher's monofilament with a stretched tail/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
• Common Device Name: 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: 12824897
• Report Number: 2032493-2021-00445
• Device Sequence Number: 19917294
• Product Code: HCG
• UDI-Device Identifier: 00810170014222
• UDI-Public: (01)00810170014222(11)181105(17)231031(10)1811055Q1
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K090891
• 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): 10/19/2021

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: 10/31/2023
• Device Model Number: 182468CS-V
• Device Catalogue Number: 182468CS-V
• Device Lot Number: 1811055Q1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2018
• 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 Age: 52 YR
• Patient Sex: Male