MAUDE Adverse Event Report: MICROVENTION, INC. COSMOS 10 ADVANCED; EMBOLIZATION COIL

Model Number	8210-0522
Medical Device Problem Codes	Detachment Of Device Component (1104); Device Issue (2379)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/11/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is used for treatment, not diagnosis.The azur system is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature.It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.Per the instructions for use: potential complications include, but are not limited to: hematoma at the site of entry, vessel/aneurysm perforation, unintended parent artery occlusion, incomplete filling, vascular thrombosis, hemorrhage, ischemia, vasospasm, edema, coil migration or misplacement, premature or difficult coil detachment, clot formation, revascularization, post-embolization syndrome, and neurological deficits including stroke and possibly death.Based on the investigation findings the root cause cannot be definitively determined as a portion of the device was not returned for evaluation.The distal segment of the delivery pusher has a broken solder joint, it cannot be determined when this occurred.(b)(4).
Event or Problem Description
It was reported from (b)(6) that during treatment of a ruptured pcom aneurysm with balloon remodeling, the coil did not detach with multiple attempts.The coil was removed and additional coils were deployed successfully.However the patient was reported to have diffusion hits in the cortex.Additional information was inquired, however no other patient status was available.

• Brand Name: COSMOS 10 ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 5575514
• Report Number: 2032493-2016-00074
• Device Sequence Number: 10857077
• Product Code: HCG
• UDI-Device Identifier: 00811425028278
• UDI-Public: (01)00811425028278(11)160201(17)210201(10)160201V2
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K050954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/21/2016

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: 02/01/2021
• Device Model Number: 8210-0522
• Device Lot Number: 160201V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2016
• Initial Report FDA Received Date: 04/13/2016
• 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: Life Threatening
• Patient Age: 56 YR