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

Model Number	ETTF3636C70E
Medical Device Problem Codes	Leak/Splash (1354); Malposition of Device (2616)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
A talent stent graft system was implanted in a patient for the endovascular treatment of a 60cm abdominal aortic aneurysm.It was reported that a ct scan revealed a type ia endoleak.It was also thought that the suprarenal stents may have fractured.Two of the suprarenal stents were still attached to the graft in the proximal aneurysm and the remaining were in the proximal neck near the renal arteries.The physician elected to implant an endurant ii aortic cuff.However, the aortic cuff was implanted approximately 1 cm distal to the intended location and the proximal type i endoleak remained.The physician then elected to implant an additional aortic cuff proximally and landed at the level of the renal artery.An angiogram the revealed that the proximal type i endoleak was resolved.A type ii endoleak was observed at the lumbar artery.The physician then elected to implant four heli-fx endoanchors to secure the aortic cuff to the existing talent stent graft as a prophylactic to prevent possible migration of the talent stent graft.The physician stated that the cause of the event could not be determined.It was noted by the physician that the cause of the slight type ia endoleak after the placement of the first cuff was due to it landing short as a result of neck tortuosity.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary the exact cause of the stent graft migration leading to the proximal type i endoleak and aaa expansion could not be determined; however, it appears likely that disease progression and morphology changes have contributed.The anatomy at implant is unknown.Review of ct¿s from 4 years post-implant revealed that a talent bifurcate was positioned just below the lowest left renal artery.The aortic body and infrarenal neck were angulated 45° a-p and 25° rt-lt relative to the iliac limbs, and the suprarenal neck angulation is 30° lt-rt.The max diameter aaa measured 53 mm and no endoleak was seen.Ct¿s from 7 <(><<)>(><(>&<)><(> <<)>)> 8 years post-implant revealed that there has been significant stent graft and morphology changes since the study at 4 years.The bifurcate has continued to migrate into the sac and was positioned ~3 ¿ 4 cm below the lowest left renal artery.One (1) or more of the bare spring apices has fractured, and the stent graft has detached from these fractured stents.The aortic body and infrarenal neck angulation has al so continued to in crease to 55° a-p and 60° rt-lt relative to the iliac limbs, and the suprarenal neck angulation has increased to 70° lt-rt.The max diameter aaa measured 77 mm and a proximal type i endoleak was observed.Images during and post aortic cuff and endoanchor implant were not available for review.It is likely that the cause of the slight type ia endoleak reported after the placement of the first cuff was due to landing short within the highly tortuous proximal neck.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 6681631
• Report Number: 2953200-2017-01064
• Device Sequence Number: 2060305
• Product Code: MIH
• UDI-Device Identifier: 00613994991515
• UDI-Public: 00613994991515
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 07/27/2017

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: 01/10/2019
• Device Model Number: ETTF3636C70E
• Device Catalogue Number: ETTF3636C70E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Initial Date Received by Manufacturer: 06/21/2017
• Supplement Date Received by Manufacturer: 07/27/2017; 07/27/2017
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 08/22/2017; 10/05/2017
• 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: 85 YR