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

Model Number 180620HC-R-V-A2

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/31/2017

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 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 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
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: debby callahan ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 7234170
• MDR Text Key: 99195881
• Report Number: 2032493-2018-00016
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777021960
• UDI-Public: (01)00816777021960(11)170601(17)220531(10)17060155V
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K050954
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR