MAUDE Adverse Event Report: MICROVENTION, INC. HYPERSOFT 3D ADVANCED; EMBOLIZATION COIL

Model Number 8410-0408

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/19/2017

Event Type  Injury  

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 not yet been returned for evaluation.The investigation is currently ongoing.

Event Description

It was reported that during a stent assisted coiling of a giant middle cerebral artery aneurysm, the 3nd coil was repositioned 4-5 times; however, the coil would not stay within the framing coil.During an attempt to remove the coil, the coil unexpectedly detached in the microcatheter, and a portion of the tail extended beyond the stent.A new catheter in combination with the bloodflow carried the tail into the stent, and an lvis jr.Stent was used to pin the coil to the vessel wall.There was no reported patient injury.The patient is reported to be doing well.

• Brand Name: HYPERSOFT 3D ADVANCED
• 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: 7043466
• MDR Text Key: 92491990
• Report Number: 2032493-2017-00292
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/13/2020
• Device Model Number: 8410-0408
• Device Lot Number: 150813LC1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/13/2015
• 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 Outcome(s): Required Intervention