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

Model Number	ETCF3636C49E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/11/2021
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 bifurcate stent graft system was implanted in the endovascular treatment of a abdominal aortic aneurysm.The patients last follow-up visit was 4 years post the index procedure.It was reported the patient presented emergently approximately 9 yeas post the index procedure with a possible ruptured aneurysm.A ct was performed which showed a type ia endoleak and a type ib endoleak coming from the right iliac attachment site.Intervention was performed where an endurant cuff was placed up to the level on the sma artery.The physician then snorkeled both renal arteries suing non mdt stents.A reliant balloon was then used to aid the fixation of the graft.The physician then placed 15 endoanchors on the cuff.An angiogram was performed which still showed a blush of endoleak present.The  physician  then decided to extend the non mdt renal stents and also snorkel the sma and place a valiant thoracic  stent graft.The valiant was then ballooned using a reliant balloon.An angiogram was performed which showed the type ia endoleak was now resolved.The physician then treated the type ib endoleak coming from the right ipsilateral limb of the bifurcated graft.An 16x16x82 iliac limb was placed to extend  the right limb.That limb was ballooned using a reliant balloon.And angiogram was performed and the type ib leak was gone.The procedure was completed.  as per the physician the cause of  the type ia endoleak was likely continued neck dilation and the ib endoleak was caused by iliac d ilation.No additional clinical sequelae were provided and the patient is fine.

• Brand Name: ENDURANT II EXTENSION CUFF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 12645472
• Report Number: 9612164-2021-03973
• Device Sequence Number: 1443205
• Product Code: MIH
• UDI-Device Identifier: 00613994991461
• UDI-Public: 00613994991461
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 10/18/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ETCF3636C49E
• Device Catalogue Number: ETCF3636C49E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 10/18/2021
• 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: Required Intervention
• Patient Age: 79 YR