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

Model Number	ETBF2513C124E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	07/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the proximal type i endoleak could not be determined from the films provided.The anatomy at implant is unknown, and earlier post-implant films were not available for comparison.Ct¿s returned from 25 months post-implant revealed that the bifurcate was positioned just below the lowest right renal artery within the severely angulated and calcified proximal neck, and there was ~10mm of remaining proximal seal length.The infrarenal neck and proximal portion of the bifurcate aortic body were acutely angulated ~75deg lt-rt between covered stent rings #2 & 3, with associated significant stent ring overlap seen along the right/inner curvature between stent rings 2 ¿ 3.The maximum aaa diameter measured 70mm, and contrast was seen within the proximal sac coming from between the proximal neck and the left side (outer curvature) of the bifurcate from a likely proximal type ia endoleak.It appears likely that an insufficient proximal seal was anatomy related caused by the angulated, short, and calcified proximal neck.It is possible that disease progression and/or aneurysm morphology changes may have also contributed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 66mm diameter abdominal aortic aneurysm.It was reported that during a follow up ct scan approximately 2 years post the index procedure a type ia endoleak was detected.Per the physician, the cause of the event cannot be determined.No additional clinical sequelae were reported, and the patient will be monitored.
Additional Manufacturer Narrative
Additional info received: an endurant cuff and 10 endoanchors were implanted during a secondary procedure 6 weeks post first observation of the endoleak.It was reported that 10 endoanchors were first used in the bifurcate and after the cuff was placed a further 3 were placed to try to resolve the type ia endoleak.The type ia endoleak was reduced significantly but failed to resolve.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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7746937
• Report Number: 2953200-2018-01131
• Device Sequence Number: 1756924
• Product Code: MIH
• UDI-Device Identifier: 00613994991225
• UDI-Public: 00613994991225
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/19/2018

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: 11/22/2017
• Device Model Number: ETBF2513C124E
• Device Catalogue Number: ETBF2513C124E
• Device Lot Number: V06244044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Initial Date Received by Manufacturer: 07/13/2018
• Supplement Date Received by Manufacturer: 08/31/2018; 08/08/2018; 10/26/2018
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 09/24/2018; 10/03/2018; 11/19/2018
• 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: 75 YR