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

Model Number	ENBF2513C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Pain (1994); Rupture (2208)
Date of Event	10/17/2017
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
An endurant stent graft system was implanted in a patient for the endovascular treatment of a 59mm diameter abdominal aortic aneurysm.However, it was reported that, approximately 6 years and 8 months post index procedure, the patient presented emergently with abdominal pain.A ct was performed and showed a type ia endoleak with a contained rupture/bulge by the renal arteries, away from the stent graft.The physician decided to treat the event using two 32x32x49 endurant aortic cuffs placed distal to the sma, covering the renal arteries and into the main body of the previous stent graft to solve the endoleak.The endoleak was not resolved and the physician elected to complete the procedure without further intervention.It was reported that, a follow up ct performed 2 days post re-intervention revealed that the endoleak had self-resolved.Per the physician the cause of the event was due to the patient's anatomy with the bulge in the patients abdominal aortic neck preventing the graft from opposing to the aortic wall.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Films review summary: the exact cause of the proximal type i endoleak leading to the aaa rupture 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 from 6- ½ years post-implant revealed that the bifurcate was positioned just below the lowest right renal artery and there was a proximal type i endoleak.The bifurcate proximal od measured ~26mm, and there was lack of stent graft radial apposition just below the renals where the neck diameter measured ~31 ¿ 33mm along a 2cm length.The neck was also severely calcified.It is possible that disease progression, with neck dilatation and severe calcification, likely contributed to the lack of a proximal seal.The cause of the endoleak seen during the intervention after two 32mm endurant aortic cuffs were implanted could not be determined.Films during this intervention were not returned, and the endoleak resolved 2-days after the intervention.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT 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: 7016899
• Report Number: 2953200-2017-01732
• Device Sequence Number: 1496201
• Product Code: MIH
• UDI-Device Identifier: 00613994762252
• UDI-Public: 00613994762252
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2017

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: 11/09/2012
• Device Model Number: ENBF2513C166E
• Device Catalogue Number: ENBF2513C166E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/18/2017
• Supplement Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 11/10/2017
• Supplement Report FDA Received Date: 12/06/2017
• 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: 63 YR