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

Model Number	181652CS-V
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/29/2018
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 has been returned to the manufacturer.The investigation is underway.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during advancement of the fifth embolization coil into a left internal carotid cavernous fistula, severe resistance was encountered.During the attempt to removal the coil, the coil detached in the microcatheter.The coil was removed in its entirety together with the microcatheter.There was no reported patient injury or intervention.The patient was reported to have been discharged a couple days post procedure.
Additional Manufacturer Narrative
The pusher was returned within the introducer for analysis; the implant was not returned.The pusher was advanced out of the introducer and examined.The proximal portions of the pusher had minor bends to the gold connector and core wire.The heater coil of the pusher seems to be wrapped and tangled with a plastic strip or tube.The plastic strip was removed from the heater coil.The strip does not look like it was part of the pusher, and appears to be from an external source.The strain relief was folded inwards, but the heater coil itself was not overly damaged and does not contain any burn damage.The resistance of the pusher was measured at 43 ohms, which is within specification.The 4-way v-grip test indicated all green lights.The attachment monofilament of the pusher was fished out for examination.The rebound length was measured at 0.0170," and the tip was stretched.There were no other notable observations.Based on the investigation findings and available information, the complaint is confirmed because the pusher was found without the implant and was most likely detached due to the device experiencing over specification pull force when the device became momentarily stuck.However, without the implant, a full investigation to the root cause of the device becoming stuck could not be performed.The source of the external plastic piece wrapped around the heater coil appears to be ptfe from the catheter that was used during the procedure.It is possible that the manipulation or condition of the implant cause damage to the catheter ptfe liner which could result in friction/getting stuck, leading to tensile separation due to excessive force.Without the evaluation of the headway microcatheter, the investigation could not confirm if the catheter was the root cause of the complaint.

• Brand Name: MICROPLEX COSMOS
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8441611
• Report Number: 2032493-2019-00060
• Device Sequence Number: 16420057
• Product Code: HCG
• UDI-Device Identifier: 00810170014147
• UDI-Public: (01)00810170014147(11)160404(17)210430(10)16040414
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K093358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2019

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: 04/30/2021
• Device Model Number: 181652CS-V
• Device Catalogue Number: 181652CS-V
• Device Lot Number: 16040414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 03/21/2019
• Supplement Report FDA Received Date: 04/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR