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

Model Number	182065CS-V
Medical Device Problem Codes	Detachment Of Device Component (1104); Difficult to Remove (1528); Stretched (1601)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history record indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The coil remains implanted and the remainder of the device was discarded at the user facility; therefore, a product analysis could not be performed.The root cause cannot be determined.
Event or Problem Description
It was reported that during embolization treatment of a large internal carotid aneurysm, an attempt was made to remove the first implanted coil; however, during withdrawal of the coil, the coil stretched almost down to the common carotid artery and then detached at the detachment zone.The proximal end of the detached coil was pushed up into the external carotid artery.An occlusion balloon test had been performed prior to the procedure to determine if it could be an option for the patient and it was successful; therefore, the decision was made to totally occlude the ica.The aneurysm was treated with additional coils and when the aneurysm was completely occluded, the coil ball mass was brought back into the ica.Finally, two amplatzer plugs were deployed in the ica proximal to the coil mass and aneurysm.There was no reported adverse patient sequelae.

• Brand Name: MICROPLEX COSMOS
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6514323
• Report Number: 2032493-2017-00100
• Device Sequence Number: 10787689
• Product Code: KRD
• UDI-Device Identifier: 00810170014185
• UDI-Public: (01)00810170014185(11)161017(17)210930(10)16101714
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 03/24/2017

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: 09/30/2021
• Device Model Number: 182065CS-V
• Device Lot Number: 16101714
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2017
• Initial Report FDA Received Date: 04/22/2017
• 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