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

Model Number	ETBF2820C166E
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Malposition of Device (2616)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/01/2018
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
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of an 65mm diameter abdominal aortic aneurysm.It was reported that a ct scan carried out approximately three years later showed a 1cm gap from the top of the graft to the lowest renal artery but there did not appear to any type ia endoleak.An intervention procedure was carried out and an 28x28x49 endurant cuff was placed to extend proximally to the level of the lowest renal artery.The cuff was ballooned and an aortogram showed no endoleak.The event was reported to be resolved.The cause of the migration is currently unknown.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.
Event or Problem Description
The physician confirmed there was no migration and the gap was most likely due to the graft being placed low originally.The physician also confirmed the type ii endoleak was from the ima.It was not device or procedure related.
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: 8068289
• Report Number: 2953200-2018-01574
• Device Sequence Number: 11332544
• Product Code: MIH
• UDI-Device Identifier: 00613994990969
• UDI-Public: 00613994990969
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 02/15/2019

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: 06/08/2016
• Device Model Number: ETBF2820C166E
• Device Catalogue Number: ETBF2820C166E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 11/19/2018; 02/05/2019
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 12/10/2018; 02/15/2019
• 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: 80 YR