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

Model Number	ENTF3636C70E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Death (1802); Pain (1994); Blood Loss (2597)
Date of Event	07/27/2017
Type of Reportable Event	Death
Event or Problem Description
A talent stent graft system was implanted in the patient for the endovascular treatment of an abdominal aortic aneurysm.An endurant stent graft system was implanted in the patient during an endovascular treatment of a 10.5cm abdominal aortic aneurysm.It was reported that the patient presented with chest pain.A type ia endoleak was discovered just below the renal arteries.The physician decided to implant heli-fx endoanchors.6 anchors were placed on the right and 3 on the left.This diminished the leak but did not eliminate it completely.The physician determined that there was a type iv endoleak in the previously implanted talent stent graft.The physician performed an open surgery on the patient and determined that the endurant stent graft had a proximal type i endoleak and the talent stent graft had a type iv fabric endoleak.The physician noted that, prior to the explant, there were at least eight tiny holes in the talent graft material that contributed to aneurysm sac growth.The physician placed a hemashield graft but the patient expired during the open procedure.Per the physician, the cause of death was due to excessive blood loss and the patient was not closed due to the excessive blood loss.The patient lost 15 liters of blood during the open procedure, coded in the intensive care unit, and expired shortly after the surgery.The physician stated that the cause of the proximal type i endoleak was due to patient aortic dilation.No additional clinical sequelae were reported.
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the proximal type i and type iii fabric endoleak could not be determined from the films provided.The anatomy at implant was not provided, and earlier post-implant films were not available for review and comparison.Returned films from ~9 years post-implant showed that a talent bifurcate was positioned near the bottom of the neck, an endurant aortic cuff was seen positioned ~3cm above the bifurcate fabric, and was located just below the right renal artery.There was a marginal proximal seal; the cuff proximal od measured ~35mm, and the aorta measured ~40mm near that same level.In addition, the cuff/bifurcate aortic body were severely angulated ~85 deg a-p near the flow divider relative to the distal aorta.The maximum aaa diameter measured ~10cm, and a localized area of contrast was seen just below the stented left renal artery.The exact cause of the reported endoleaks could not be determined.It is likely that the proximal type i was caused by disease progression; neck dilatation.The cause of the reported type iii fabric endoleak observed via angiogram could not be determined.Images during the endoanchor intervention and post-intervention films where the endoleak was reported were not available for review, and the precise location of the endoleak is unknown.It is possible that the observed severe stent graft angulation may have contributed to the type iii fabric endoleak.If information is provided in the future, a supplemental report will be issued.

• 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: 6819832
• Report Number: 2953200-2017-01331
• Device Sequence Number: 18848193
• Product Code: MIH
• UDI-Device Identifier: 00613994762023
• UDI-Public: 00613994762023
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2017

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: 01/18/2014
• Device Model Number: ENTF3636C70E
• Device Catalogue Number: ENTF3636C70E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Initial Date Received by Manufacturer: 08/01/2017
• Supplement Date Received by Manufacturer: 09/22/2017
• Initial Report FDA Received Date: 08/25/2017
• Supplement Report FDA Received Date: 10/17/2017
• 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: Death; Required Intervention
• Patient Age: 79 YR