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

Model Number 100412CSSR-V

Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2019

Event Type  malfunction  

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 Description

It was reported that during advancement of an embolization coil, the coil got stuck in the middle of the microcatheter and detached.The coil was removed in its entirety together with the microcatheter.There was no reported patient injury or intervention.

Manufacturer Narrative

The pusher, implant, and introducer were returned for analysis.The implant was found to still be attached to the pusher.The coil retained most of its shape, and had some damaged and offset coils near the distal portion.The pusher was found to be undamaged; the body coils and proximal solder joints were in good condition.No damage was observed to the introducer tip.The implant was slightly pulled at the marker band and confirmed the monofilament was still attached to the implant and pusher.The microcatheter was not returned with the device and the complaint did not specify the type of microcatheter used for the procedure.A new headway 17 was used to test for friction.The device was loaded through the introducer and into the headway 17, and no friction was observed during the test.The implant successfully advanced out of the distal portion of the microcatheter.Based on the available information and evaluation of the device, the reported complaint cannot be confirmed.The coil was still attached to the pusher, and successfully loaded through a compatible microcatheter without friction.The device was noted to be within specification and functioned as intended.Because the returned device was found unbroken, contrary to what was reported, there may be an issue with the accuracy of what was reported.There is also the possibility that the device that was returned was the incorrect device.

• Brand Name: MICROPLEX COSMOS 10 VTA
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8458607
• MDR Text Key: 140120895
• Report Number: 2032493-2019-00067
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777021694
• UDI-Public: (01)00816777021694(11)171027(17)220930(10)171027564
• Combination Product (y/n): N
• PMA/PMN Number: K082461
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2022
• Device Model Number: 100412CSSR-V
• Device Lot Number: 171027564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Date Manufacturer Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 80