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

Model Number	182468CS-V
Medical Device Problem Codes	Detachment Of Device Component (1104); Difficult To Position (1467); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records 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 device was returned with the implant detached from the pusher.The resistance of the pusher was within specifications.The v-grip used for the procedure was not returned; however, the v-grip used for testing showed a green light for all four (4) angular locations.The pet covering the heater coil was intact, and no evidence of thermal damage was observed.The rebound on the monofilament on the pusher side was indicative of good tension in the monofilament; however, the severed end of the monofilament showed striations and was necked down, thus indicating the monofilament stretched and then broke under tension.Results of the product evaluation confirmed stretching and tensile break of the monofilament, with no evidence of thermal detachment, which is consistent with the monofilament being subjected to a force exceeding its tensile strength.The force exerted during retraction of the pusher system exceeded the attachment monofilament maximum tensile specifications.
Event or Problem Description
It was reported that coil embolization treatment was performed for a cavernous ica aneurysm.Positioning the coil was difficult, so an attempt was made to remove the coil.During the withdrawal, resistance was encountered and then the coil detached.No intervention was performed and the coil remains implanted in the aneurysm.There was no reported patient injury.The patient is currently reported to be doing well.

• Brand Name: MICROPLEX COSMOS 18
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6474421
• Report Number: 2032493-2017-00084
• Device Sequence Number: 608597
• Product Code: HCG
• UDI-Device Identifier: 00810170014222
• UDI-Public: (01)00810170014222(11)161201(17)211130(10)16120114
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K090891
• 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): 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 11/30/2021
• Device Model Number: 182468CS-V
• Device Lot Number: 16120114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2017
• Initial Report FDA Received Date: 04/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1