MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM PRIME BRPL 3D; DEVICE, EMBOLIZATION, VASCULAR

Model Number	APB-5-8-3D-SS
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Death (1802); Foreign Body In Patient (2687)
Date of Event	07/17/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device was not returned for analysis.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.Attempts to gather additional event details have been made, however, no information has been received.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that during the use of the axium prime coil, the coil was reported to have stretched.This event has been alleged to have caused a patient death.Medical / surgical intervention was required, and the hospitalization was extended.The anatomy was reported to have been severe in tortuosity.The devices were prepared and used per the instructions for use (ifu).A continuous flush was used during the procedure.
Event or Problem Description
Medtronic received additional event information: medtronic received a report of patient death after axium prime placement.The patient was undergoing coil embolization of a bifurcating aneurysm in the left middle cerebral artery.The aneurysm was described as small with a 5mm dome.The anatomy was reported to have been severe in tortuosity.The devices were prepared and used per the instructions for use (ifu).A continuous flush was used during the procedure.At baseline, the patient had wfns of 1.It was reported that during the procedure, the axium was advanced through the catheter (model/lot unknown) with resistance.The coil was repositioned three times and reportedly became stretched.The coil became detached and was implanted in an unintended location ("incorrect posting").There were reportedly no detachment attempts made.Medical / surgical intervention was required, and the hospitalization was extended.The patient reportedly passed away due to "incorrect posting after ev3 detachment use.".
Additional Manufacturer Narrative
Patient information - additional information.Date manufacturer received - additional information.Patient codes, device codes - additional information.Type of report - additional information.Follow-up type - additional information.Additional manufacturer narrative - 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.

• Brand Name: AXIUM PRIME BRPL 3D
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8841528
• Report Number: 2029214-2019-00793
• Device Sequence Number: 10834350
• Product Code: KRD
• UDI-Device Identifier: 00847536008243
• UDI-Public: 00847536008243
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/22/2019
• Device Model Number: APB-5-8-3D-SS
• Device Lot Number: A348527
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 09/04/2019
• 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
• Patient Age: 60 YR
• Patient Weight: 70