MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM NYLON HLX; DEVICE, EMBOLIZATION, VASCULAR

Model Number	NC-4-10-HELIX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	03/05/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
The coil has not been returned as it remains implanted in the patient; product analysis cannot be performed.Based on the reported information, there does not appear to have been any defect of the device during use.The event occurred in the patient post-procedure and its cause could not be conclusively determined from the reported information.Mdrs related to this event: 2029214-2019-00289, 2029214-2019-00290, 2029214-2019-00291, 2029214-2019-00292, 2029214-2019-00293, 2029214-2019-00294, 2029214-2019-00295, 2029214-2019-00296, 2029214-2019-00297.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report of patient death after coiling.The patient presented with hemorrhage.The patient had a ruptured, saccular aneurysm.It was reported that the patient underwent coiling in order to improve the situation.The patient underwent implantation of 13 coils including 9 medtronic coils.The patient reportedly passed away post-procedure due to the massive hemorrhage.

• Brand Name: AXIUM NYLON HLX
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8483690
• Report Number: 2029214-2019-00290
• Device Sequence Number: 11208699
• Product Code: KRD
• UDI-Device Identifier: 00836462011106
• UDI-Public: 00836462011106
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/11/2021
• Device Model Number: NC-4-10-HELIX
• Device Catalogue Number: NC-4-10-HELIX
• Device Lot Number: A706328
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death