MAUDE Adverse Event Report: EV3 NEUROVASCULAR AXIUM PLATINUM HELICAL DETACHABLE COIL; DETACHABLE COIL, PRODUCT CODE: HCG

Model Number QC-1.5-2-HELIX

Device Problem Sticking (1597)

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

Event Date 08/12/2014

Event Type  malfunction  

Event Description

Treatment of an mca (middle cerebral artery) bifurcation aneurysm.On (b)(6) 2014, the pt underwent stent assisted coiling treatment.During the procedure, it was reported the physician used an axium 3d coil to frame the aneurysm with some manipulation.The physician then attempted to detach the implant coil with the instant detacher, but subsequent fluoroscopy revealed that the implant coil did not detach.Another attempt was made to detach the implant coil with the instant detacher, but without success.An attempt was also made to detach the implant coil via the manual method (breaking of the hypotube, an alternative detachment method presented in the instruction for use), but this also proved to be unsuccessful on fluoroscopy.The implant coil was removed from the pt still attached to the pushwire.No pt injury was reported as a result of the procedure.

Manufacturer Narrative

The pusher assembly was returned for eval with the implant coil still attached.The instant detacher was not returned.The implant coil was found stuck at the coil shield with dried blood; however, the cause could not be determined.All products are 100% inspected for damages and irregularities during manufacture.(b)(4).

• Brand Name: AXIUM PLATINUM HELICAL DETACHABLE COIL
• Type of Device: DETACHABLE COIL, PRODUCT CODE: HCG
• Manufacturer (Section D): EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: michael nguyen ; 9775 toledo way; irvine, CA 92618 ; 9496801558
• MDR Report Key: 4095085
• MDR Text Key: 4831829
• Report Number: 2029214-2014-00521
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/18/2016
• Device Model Number: QC-1.5-2-HELIX
• Device Lot Number: 9804546
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2013
• 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