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

Model Number	ENCF3232C49E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	03/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii extension cuff and an anuerx stent graft system were implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm of unknown size.It was reported that the patient presented emergently, approximately 8 years post implant, with a ruptured aneurysm, due to a type ia endoleak.It was reported that the endurant cuff had lost proximal seal, leading to the type ia endoleak.The physicians implanted an additional endurant ii cuff and 12 heli-fx endoanchors as treatment, intentionally covering the patient's renal arteries in order to gain a more robust proximal seal.A reliant balloon was used to iron the cuff.An angiogram was then performed, which showed continual filling within the aneurysm from the type ia endoleak.The physicians then re-ballooned using the reliant and implanted a further 4 endoanchors within the stent graft material.Another angiogram was then performed, showing that there was still some filling within the aneurysm.The physicians elected to end the procedure and obtain a follow-up ct on a later date.The physician stated the cause of the event was anatomy related, due to disease progression.No additional clinical sequelae were reported and the patient will be monitored by their physician.

• Brand Name: ENDURANT EXTENSION CUFF STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8435513
• Report Number: 2953200-2019-00381
• Device Sequence Number: 277914
• Product Code: MIH
• UDI-Device Identifier: 00613994762085
• UDI-Public: 00613994762085
• 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: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/20/2019

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: 12/08/2012
• Device Model Number: ENCF3232C49E
• Device Catalogue Number: ENCF3232C49E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 03/20/2019
• 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: Required Intervention
• Patient Age: 87 YR