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

Model Number	181347CS-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	10/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformance 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 has not been returned to the manufacturer for evaluation.If the device is received, an investigation will be performed and a supplemental report will be submitted.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during an embolization treatment of a basilar aneurysm, the second coil became stuck within the microcatheter.Upon withdraw the coil detached from the delivery pusher within the microcatheter.The coil and microcatheter were withdrawn together and the procedure was completed successfully.No patient harm or injury was reported.
Additional Manufacturer Narrative
Additional information: h10 (summary device evaluation).Summary of device evaluation: the reported complaint is confirmed.The investigation of the returned coil system found the implant separated from the pusher, stretched at proximal and stuck inside the returned microcatheter.The pusher was received with no signs of activation on the pusher's heater coil and the attachment monofilament profiles a stretched tail shape at the tip.The returned microcatheter was found damaged 1.5" from the distal end.This damage creates a decrease in inner diameter, which would cause increased resistance/friction during retraction.The investigation determined the separation of the implant is consistent with the implant becoming stuck and then experiencing retraction forces that exceeded the strength of the monofilament.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: terry callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 12807831
• Report Number: 2032493-2021-00441
• Device Sequence Number: 14824017
• Product Code: HCG
• UDI-Device Identifier: 00810170014116
• UDI-Public: (01)00810170014116(11)180719(17)230630(10)1807195V6
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2021

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: 06/30/2023
• Device Model Number: 181347CS-V
• Device Catalogue Number: 181347CS-V
• Device Lot Number: 1807195V6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 11/12/2021
• Supplement Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2018
• 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 Sex: Unknown