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

Model Number	NC-3-4-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 7 medtronic coils.The patient reportedly passed away post-procedure due to the massive hemorrhage.Pes related to this patient: (b)(4) intraprocedural malfunction (b)(4); post-procedure event.
Additional Manufacturer Narrative
Event description - correction date manufacturer received - additional information type of report - additional information follow-up type - additional information.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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: 8483673
• Report Number: 2029214-2019-00289
• Device Sequence Number: 1486883
• Product Code: KRD
• UDI-Device Identifier: 00847536013162
• UDI-Public: 00847536013162
• 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,Followup
• 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: 10/16/2020
• Device Model Number: NC-3-4-HELIX
• Device Lot Number: A540411
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement 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