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

Model Number	182263CS-V
Medical Device Problem Codes	Detachment Of Device Component (1104); Difficult to Remove (1528)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.A review of the device history records indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints reported for this lot number.The device remains implanted in the patient, and the remainder of the device was discarded at the user facility; therefore, a product analysis will not be performed.The root cause cannot be determined.The instructions for use (ifu) states that, "potential complications include, but are not limited to: hematoma at the site of entry, vessel perforation, aneurysm rupture, parent artery occlusion, incomplete aneurysm filling, emboli, hemorrhage, ischemia, vasospasm, coil migration or misplacement, premature or difficult coil detachment, clot formation, revascularization, postembolization syndrome, and neurological deficits including stroke and possibly death.".
Event or Problem Description
It was reported that during treatment of a giant basilar tip aneurysm, the coil unexpectedly detached during implantation.An attempt was made to remove the coil with a snare device; however, it was not successful.The coil was implanted partially in the aneurysm and down into the basilar artery.Sometime after the procedure, the patient experienced bleeding and is receiving ongoing treatment.The patient was also treated for vasospasm.It was stated that this procedure was the third attempt to treat the patient, and it was a challenging case.It is unknown if there was a relationship between the coil and the patient bleed.

• Brand Name: MICROPLEX COSMOS
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7135859
• Report Number: 2032493-2017-00337
• Device Sequence Number: 16423838
• Product Code: KRD
• UDI-Device Identifier: 00810170014208
• UDI-Public: (01)00810170014208(11)151210(17)201231(10)15121014
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K102365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/30/2017

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: 12/31/2020
• Device Model Number: 182263CS-V
• Device Lot Number: 15121014
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 12/20/2017
• 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: 59 YR