MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT II BIFURCATED STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	ETBF2816C145E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Anemia (1706); Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)
Date of Event	02/14/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: etlw1628c93e, serial/lot #: (b)(4), ubd: 14-jun-2014, udi#: (b)(4).Product id: sg-64, serial/lot #: (b)(4), ubd: 14-jun-2014.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system was implanted in the endovascular treatment of a 95mm abdominal aortic aneurysm.During this procedure a heli -fx endoanchoring system was used for an apparent type ia endoleak and seven endoanchors were implanted.This resolved the endoleak.During the index procedure it was reported that the patient was hypotensive, bleeding and anemic.It was reported that the patient had an estimated blood loss of 400mls.This was then treated and the patient received an infusion of 2 units of red blood cells, was given medication and had diagnostic imaging performed.It was confirmed that the endoanchors were used in this procedure for both a concern for late failure and for a type ia endoleak.It was reported that four endoanchors were used to secure the trunk due to a short angulated neck and a further three endoanchors were implanted as a final arteriogram demonstrated a persistent flow coming from the right lateral aspect of the device which was confirmed to be the ia endoleak.This event was reported to have resolved four days later and recovered with treatment.Final arteriogram showed the endoleak had resolved.This event has been assessed by the site as being related to the index procedure.
Additional Manufacturer Narrative
Correction to h6: patient code updated.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: ENDURANT II BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9762649
• Report Number: 9612164-2020-00908
• Device Sequence Number: 2778626
• Product Code: MIH
• UDI-Device Identifier: 00613994991324
• UDI-Public: 00613994991324
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2020

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: 10/13/2014
• Device Model Number: ETBF2816C145E
• Device Catalogue Number: ETBF2816C145E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 10/12/2020
• 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: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 90