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

Model Number	ETBF2316C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Death (1802); Low Blood Pressure/ Hypotension (1914)
Date of Event	02/28/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
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 a patient for the endovascular treatment of a 55mm abdominal aortic aneurysm.It was reported approximately 6 years post the index procedure the patient presented emergently.A type iv endoleak or graft tear was suspected.Intervention was completed with a non mdt stent implanted to reline the endurant stent graft.It was reported the patient had continuing hypotension after the stent was relined and the physician elected to convert to open repair however it was reported the patient expired.Per the physician the cause of the event is anatomy related.The cause of death is undetermined.

• 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: 8386396
• Report Number: 2953200-2019-00304
• Device Sequence Number: 2227660
• Product Code: MIH
• UDI-Device Identifier: 00613994991218
• UDI-Public: 00613994991218
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2019

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: 09/18/2015
• Device Model Number: ETBF2316C166E
• Device Catalogue Number: ETBF2316C166E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 03/04/2019
• 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; Required Intervention
• Patient Age: 72 YR