MAUDE Adverse Event Report: MICROVENTION, INC. COSMOS 18 ADVANCED; EMBOLIZATION COIL

Model Number	8218-1347
Medical Device Problem Codes	Detachment Of Device Component (1104); Device Issue (2379)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	07/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided.The root cause of this complaint cannot be determined.The implant remains within the patient in the intended location.No portion of the device was returned for evaluation, it was reported discarded.(b)(4).
Event or Problem Description
It was reported that during the embolization treatment of an avm off a vertebral feeder artery, the embolization coil was positioned in the feeder artery.After 50% of the coil was positioned, the coil prematurely detached within the artery.The remaining coil (outside of the intended location) was tacked in place using 2 wingspan stents to keep the coil intact against the vessel wall successfully.The patient was reported to be okay.

• Brand Name: COSMOS 18 ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 5907017
• Report Number: 2032493-2016-00197
• Device Sequence Number: 634105
• Product Code: HCG
• UDI-Device Identifier: 00811425028797
• UDI-Public: (01)00811425028797(11)150910(17)200910(10)150910V7
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K093358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/28/2016

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: Physician
• Device Expiration Date: 09/10/2020
• Device Model Number: 8218-1347
• Device Lot Number: 150910V7
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2016
• Initial Report FDA Received Date: 08/26/2016
• 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: 64 YR