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

Model Number 100202HS-V

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

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 implant coil and pusher were returned partially stuck in the microcatheter.The pusher and coil were removed and noted to be entangled.The remaining portion of the pusher was note to be separated.A kink was noted near the gold connector portion, and the lead wires were separated.Based on the investigation findings and available information, the reported complaint could be confirmed; the coil was noted to be entangled, and lead wires were separated.The root cause could not be determined; however, the device exhibited evidence that it was subjected to forces that exceeded its strength specifications.

Event Description

It was reported that during treatment for an anterior communicating artery aneurysm, the microcatheter backed out of the aneurysm into the vessel during placement of the 5th embolization coil.While trying to resheath the coil, the coil did not move; therefore, the coil was removed in its entirety together with the microcatheter.After removal, the pusher wire was noted to have stretched and detached in the catheter.There was no reported intervention or patient injury.The patient is reported to be doing fine.

• Brand Name: MICROPLEX HYPERSOFT HELICAL
• 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: 7393803
• MDR Text Key: 104547988
• Report Number: 2032493-2018-00060
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K050954
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2018
• Device Model Number: 100202HS-V
• Device Lot Number: 130528H8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2013
• 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: 39 YR