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

Model Number	8210-0522
Medical Device Problem Codes	Stretched (1601); Device Issue (2379)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is used for treatment, not diagnosis.The microplex coil system (mcs) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.The mcs is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.Per the instructions for use: 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, post-embolization syndrome, and neurological deficits including stroke and possibly death.Cases of chemical aseptic meningitis, edema, hydrocephalus and/or headaches have been associated with the use of embolization coils in the treatment of large and giant aneurysms.The physician should be aware of these complications and instruct patients when indicated.Appropriate patient management should be considered.Based on the information provided, the complaint cannot be confirmed.The device could not be evaluated as it was reported not available.(b)(4).
Event or Problem Description
It was reported from (b)(4) during the embolization treatment of an aneurysm, the coil was deployed successfully.Upon removal of the delivery pusher it was reported to stretch and break.Clot developed in the neck of the aneurysm and reopro was administered.The patient was reported to awake without deficit and went home clinically intact.Mr performed 1 day post tx showed no infarct.

• Brand Name: COSMOS 10 ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 5657568
• Report Number: 2032493-2016-00097
• Device Sequence Number: 13540757
• Product Code: HCG
• UDI-Device Identifier: 00811425028278
• UDI-Public: (01)00811425028278(11)151130(17)201130(10)151130V2
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K102365
• 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): 04/21/2016

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: 11/30/2020
• Device Model Number: 8210-0522
• Device Lot Number: 151130V2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2016
• Initial Report FDA Received Date: 05/16/2016
• 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