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

Model Number	ETCF2525C49E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/08/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm.It was reported that a recent ct revealed a proximal type i endoleak and a recent angiogram confirmed the proximal type i endoleak.A 25x25 endurant aortic cuff was implanted in the proximal portion of the endurant bifurcated stent graft however the proximal type i endoleak was not resolved.The physician elected to implant another manufacturer¿s 40x10 bare metal stent mounted on a balloon at the level of the endurant bifurcated stent graft, because the other manufacturer¿s stent could not be advanced to the intended landing zone.The physician inserted another manufacturer¿s 16x35cm sheath enabling advancement and deployment of a second device (another manufacturer¿s stent on another manufacturer¿s balloon) at the level of the endurant aortic cuff.An angiogram was performed and the proximal type i endoleak was resolved.The physician stated that the causes of the proximal type i endoleak could not be determined.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the possible proximal type i endoleak leading to aneurysm enlargement cannot be conclusively determined from the films provided.Films at implant and earlier post-implant films were not returned for review.However, the infrarenal aortic neck appeared to have dilatated post implant, possibly due to disease progression.In addition, the pre-implant cta's showed that the infrarenal aortic neck was highly angulated and contained mild thrombus.It is possible that implanting the bifurcate stent graft in a highly angulated and off-label aortic neck that contained thrombus, combined with aortic neck dilatation from disease progression, may have contributed to the events.The exact cause of the residual proximal type i endoleak after implant of the 25mm diameter endurant aortic cuff cannot be conclusively determined from the films provided.The films during the secondary intervention, where the endurant aortic cuff was implanted, was not returned for review.However, the cta's that was done approximately 2-months prior to the secondary intervention showed that the proximal aortic neck diameter measured approximately 28 mm.It is possible that insufficient oversizing, implanting a 25 mm diameter endurant aortic cuff in a 28 mm diameter aortic neck, may have contributed.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II EXTENSION CUFF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6375133
• Report Number: 2953200-2017-00328
• Device Sequence Number: 18983413
• Product Code: MIH
• UDI-Device Identifier: 00613994991430
• UDI-Public: 00613994991430
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2017

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: 05/19/2018
• Device Model Number: ETCF2525C49E
• Device Catalogue Number: ETCF2525C49E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Initial Date Received by Manufacturer: 02/08/2017
• Supplement Date Received by Manufacturer: Not provided; 03/28/2017
• Initial Report FDA Received Date: 03/02/2017
• Supplement Report FDA Received Date: 04/06/2017; 09/29/2017
• 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: 84 YR