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

Model Number	ETBF2516C145E
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 50mm diameter abdominal aortic aneurysm.It was reported that approximately 3.5 years post index procedure a follow up ct scan indicated a type ia endoleak with aneurysm expansion.Per the physician, the cause of the event is unknown.No additional clinical sequelae were reported, and the patient will be monitored.
Additional Manufacturer Narrative
Films review summary: the exact cause of the reported proximal type i endoleak and aaa expansion could not be determined from the films provided.The anatomy at implant is unknown, and earlier post-implant films were not available for review and comparison.Ct¿s returned from 42 months post-implant revealed that the maximum diameter aaa measured ~63mm, with contrast was seen outside the stent graft from an unknown endoleak.The exact source and cause of the endoleak could not be determined.The bifurcate was positioned ~5mm below the lowest right renal artery, the neck diameter ranged from ~22 ¿ 25mm along the 15mm neck length, and the neck and top of the aaa sac were extensively calcified.Contrast was seen beginning at the top of the aaa sac outside the anterior of the bifurcate aortic body near the 2nd covered stent.While it is possible that the endoleak was from a proximal type i endoleak possibly caused by a marginal proximal neck potentially due to disease progression, the contrast was observed near a large area of aortic calcification, therefore a type iii fabric endoleak also cannot be ruled out.In addition, potential retrograde filling from a vessel entering the proximal aaa sac was also possible.Angiograms which may have included endoleak interrogation to help determine the source and rule out other potential endoleak sources were not provided; thereby, making determination of the endoleak challenging from the ct¿s provided.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: 7681059
• Report Number: 2953200-2018-01008
• Device Sequence Number: 11408173
• Product Code: MIH
• UDI-Device Identifier: 00613994991263
• UDI-Public: 00613994991263
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2016
• Device Model Number: ETBF2516C145E
• Device Catalogue Number: ETBF2516C145E
• Device Lot Number: V05936860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 07/20/2018; 08/08/2018; 08/08/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 07/24/2018; 10/02/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR