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

Model Number	ETBF3216C145E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	11/03/2017
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 52 mm diameter abdominal aortic aneurysm.It was reported that a ct scan performed approximately 3 years post index procedure showed what was thought to be a type ii endoleak.During the scan it was also noted that the aaa has grown from 5.2 cm at implant to 5.5 cm.After further review of the ct scan and the angiogram it was determined that the patient has a proximal type 1 endoleak.Per the physician the event was anatomy related (disease progression).No additional clinical sequelae were reported and the patient will be monitored by their physician.
Additional Manufacturer Narrative
Additional information received for this case reported that approximately 3 years post index procedure, the physician placed a 32/32 /49 endurant cuff followed by 7 endoanchors.There was no endoleak on the final angiogram.No additional clinical sequelae were reported and the patient is fine.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: 7062632
• Report Number: 2953200-2017-01860
• Device Sequence Number: 10788462
• Product Code: MIH
• UDI-Device Identifier: 00613994990983
• UDI-Public: 00613994990983
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 01/03/2018

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: 08/13/2016
• Device Model Number: ETBF3216C145E
• Device Catalogue Number: ETBF3216C145E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/03/2017
• Supplement Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 11/28/2017
• Supplement Report FDA Received Date: 01/03/2018
• 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: 78 YR