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

Model Number	180723CS-V
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformance 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.Customer supplied images were reviewed by microvention's product safety physician: the images displayed a coil mass with a section of embolic coil extending beyond the coil mass.In one of those images, the delivery catheter can also be seen with what appears to be a broken or separated section of embolic coil extending past the distal end of the delivery catheter.Both of these fluoroscopic images are consistent with the complaint.The device was not returned to the manufacturer for evaluation.The root cause could not be determined.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.
Event or Problem Description
It was reported that treatment was performed on a ruptured internal carotid artery aneurysm.During placement and repositioning of the 8th coil, the coil unexpectedly detached in the carotid artery and there was a temporary hiccup flow.A snare was used to retrieve the detached coil segment.There was no reported patient injury or sequela.

• Brand Name: MICROPLEX COSMOS
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 9760301
• Report Number: 2032493-2020-00048
• Device Sequence Number: 688059
• Product Code: HCG
• UDI-Device Identifier: 00810170014055
• UDI-Public: (01)00810170014055(11)190103(17)231231(10)1901031R1
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• PMA/510(K) Number: K090891
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2023
• Device Model Number: 180723CS-V
• Device Catalogue Number: 180723CS-V
• Device Lot Number: 1901031R1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 77