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

Model Number	ENEW1313C82E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/01/2017
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 iis stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm.It was reported that the patient contacted technical services to report that she had received a card in the post about her implanted device.Until this time, the patient states she had no knowledge that she had had stent grafts implanted in her, neither did she know that follow up was needed for them.Patient reported that she had been treated already for an endoleak that has occurred and is scheduled for the repair of another endoleak with a different physician to the original physician who implanted the device.Patient states that she had symptoms that "kept me in bed" since approximately 4 years post index procedure and this led to the endoleak repair.According to the implanting physician, the patient was lost to follow up.A ct had revealed that the aneurysm was getting larger and the patient was referred to another facility to treat what may have been a type ii endoleak.The implanting physician has not seen the patient since that time and therefore cannot provide any information regarding the alleged new endoleak.No other clinical sequelae were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: the patient phoned technical services to question whether endoleaks noted post implantation of the stent grafts could be related to having stent grafts upgrade.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7016901
• Report Number: 2953200-2017-01734
• Device Sequence Number: 1394138
• Product Code: MIH
• UDI-Device Identifier: 00613994762153
• UDI-Public: 00613994762153
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2019

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: 01/24/2014
• Device Model Number: ENEW1313C82E
• Device Catalogue Number: ENEW1313C82E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/18/2017
• Supplement Date Received by Manufacturer: 01/05/2018; 09/16/2019
• Initial Report FDA Received Date: 11/10/2017
• Supplement Report FDA Received Date: 01/12/2018; 10/10/2019
• 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: 69 YR