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

Model Number	ETUF3614C102E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Death (1802); Rupture (2208)
Date of Event	05/11/2019
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
A talent stent graft system was implanted in a patient for the endovascular treatment of a ruptured abdominal aortic aneurysm.It was reported approximately 11 years post the index procedure, the patient presented with a ruptured abdominal aneurysm.Ct revealed the talent graft had migrated down from the renals with the rupture noted at the proximal end of the graft.Intervention was completed where the physician elected to implant an endurant aui graft.The procedure was performed under short neck indication.A type ia endoleak was then observed.Heli-fx endoanchors were implanted however the endoleak remained.A occluder was implanted on the left and an endurant limb (etlw1624c124e) on the right.It was reported the physician could not achieve a seal proximally and decided to implant a non mdt non aortic cuff proximally to the endurant aui.The cuff did not land where expected.The physician suspected a junctional leak and implanted an additional cuff covering the left renal.On the final run, the type ia endoleak was still observed.A fem-fem was then performed.It was then reported the patient expired.Per the physician the cause of the type ia endoleak and migration are undetermined.The cause of death was due to the ruptured abdominal aorta.

• Brand Name: ENDURANT II AUI STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8673824
• Report Number: 9612164-2019-02195
• Device Sequence Number: 16731783
• Product Code: MIH
• UDI-Device Identifier: 00643169232631
• UDI-Public: 00643169232631
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/06/2019

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: 10/17/2019
• Device Model Number: ETUF3614C102E
• Device Catalogue Number: ETUF3614C102E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 06/06/2019
• 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: 80 YR