MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX HYPERSOFT HELICAL VTA; EMBOLIZATION COIL

Model Number	100206HS-V
Medical Device Problem Codes	Detachment Of Device Component (1104); Difficult To Position (1467)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	03/19/2018
Type of Reportable Event	Serious Injury
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 pusher was returned for evaluation; the implant coil was not returned.The distal black pet on the heater coil section was noted to be burned.There were several kinks on the pusher.The attachment section had a secure tie-knot.The pusher was dissected to expose the attachment tether to determine the type of detachment.The attachment tether tip demonstrated a mushroom and a rebound length of (b)(6),' which is indicative of a thermal detachment.Based on the available information and evaluation of the returned device, the complaint cannot be verified as the implant coil segment was missing.However, the pusher exhibited evidence of a normal thermal detachment.The investigation was limited by not having the coil section of the implant to analyze.The instructions for use (ifu) identifies thrombus as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during the placement of the last embolization coil in a giant saccular aneurysm, the coil "moved" partially inside the stent.During a withdrawal attempt, the coil detached partially inside the stent.Thrombus was noted inside the stent, which was treated successfully with aggrastat.The patient's current status is reported to be stable.

• Brand Name: MICROPLEX HYPERSOFT HELICAL VTA
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7443471
• Report Number: 2032493-2018-00071
• Device Sequence Number: 1976420
• Product Code: HCG
• UDI-Device Identifier: 00816777020628
• UDI-Public: (01)00816777020628(11)170602(17)220531(10)17060254R
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K050954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/22/2018

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: 05/31/2022
• Device Model Number: 100206HS-V
• Device Lot Number: 17060254R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 04/19/2018
• 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