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

Model Number	ETBF3616C166E
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 an unknown size abdominal aortic aneurysm.It was reported that on a ct exam performed approximately 8 years post index procedure a type ia endoleak with migration of the stent graft was observed.As per the physician, the cause of the event may be related to disease progression in the aneurysmal neck.It was reported that an intervention was carried out to treat the type ia endoleak.It was planned to reline the talent stent graft with a endurant ii bifurcation stent graft during the procedure and place endoanchors is the proximal main body due to the wide angulated neck.It was reported that following deployment of the endurant ii bifurcation stent graft it was determined by multiple angled fluoroscopy that the graft was loaded backwards in the delivery system.The gate was 180 degrees from the blue dot on the delivery system.It was reported that due to this unplanned posterior position, gate cannulation proved difficult.It was also reported the gate was severely compressed due to the extreme angulation of the aorta.The gate could not be successfully cannulated.An aui and endurant ii limb extension were implanted on the right-hand side and a plug was placed in the left limb of the talent stent graft.A left to right fem-fem bypass was also carried out.No additional clinical sequelae were reported and the patient is fine.
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: 7537017
• Report Number: 2953200-2018-00753
• Device Sequence Number: 11227848
• Product Code: MIH
• UDI-Device Identifier: 00613994991041
• UDI-Public: 00613994991041
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2018

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: 06/28/2019
• Device Model Number: ETBF3616C166E
• Device Catalogue Number: ETBF3616C166E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 09/28/2018
• 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: 72 YR
• Patient Weight: 136