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

Model Number	ETLW1616C199E
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Rupture (2208); Insufficient Information (4580)
Date of Event	05/21/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: esbf3214c103e, serial/lot #: (b)(4), ubd: 29-jan-2021, udi#: (b)(4) ; product id: etlw1628c199e, serial/lot #: (b)(4), ubd: 09-jan-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant navion stent graft system were implanted in a patient for the endovascular treatment of an unknown size thoracic aortic aneurysm.It was reported that 2 and a half years later, a ct images were reviewed, where a endoleak type 1b was noted.It was reported the type ib endoleak appeared to touch both of the implanted devices.It was reported an additional two surgical repair procedures were performed and the patient expired during the second procedure.It was reported the cause of death was an intra-operative ruptured aneurysm.It was noted that during the first intervention procedure, an endurant iis bifurcate stent graft system was implanted along with a valiant navion stent graft.The patient reportedly expired during the second procedure where two further stent grafts had been implanted, a endurant limb and a valiant navion stent graft.No additional clinical sequalae were reported and the patient is expired.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 12238464
• Report Number: 9612164-2021-02904
• Device Sequence Number: 17081587
• Product Code: MIH
• UDI-Device Identifier: 00643169467651
• UDI-Public: 00643169467651
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/28/2021

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: 08/14/2020
• Device Model Number: ETLW1616C199E
• Device Catalogue Number: ETLW1616C199E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 07/28/2021
• 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; Other; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 85