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

Model Number	180620HC-R-V-A2
Medical Device Problem Codes	Detachment Of Device Component (1104); Difficult To Position (1467)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/31/2017
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 to the manufacturer for analysis.The pusher was noted to have a bend in the hypotube section.The transition joint (hypotube-body coil) was broken at the laser weld into two halves; however, the pet was still intact.The implant was provided separately and noted to be in good condition, without any damage or deformities.The coil also had the attachment tether unsevered.The heater coil section was noted to be in conformance as well.The attachment tether demonstrated a stretched tail configuration, indicating non-thermal detachment.Based on the reported complaint and evaluation of the returned product, the stretched and broken coil indicated that excessive force had been applied to the device, which exceeded its maximum tensile specification.
Event or Problem Description
It was reported that after several coils had been placed in a 13mm aneurysm, difficult advancement of the coil was encountered.During re-positioning and retraction of the coil, the coil detached in the microcatheter.Both segments of the coil were removed together with the microcatheter.There was no reported intervention or patient injury.The patient is reported to be doing well.

• Brand Name: MICROPLEX HELICAL REGULAR VTA
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7234170
• Report Number: 2032493-2018-00016
• Device Sequence Number: 2116815
• Product Code: HCG
• UDI-Device Identifier: 00816777021960
• UDI-Public: (01)00816777021960(11)170601(17)220531(10)17060155V
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 01/02/2018

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: 05/31/2022
• Device Model Number: 180620HC-R-V-A2
• Device Lot Number: 17060155V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 02/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR