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

Model Number	ETLW1628C156E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	11/28/2017
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 ii stent graft system was implanted in a patient for the endovascular treatment of an unknown sized abdominal aortic aneurysm.It was reported that the patient presented emergently at the emergency department with severe back pain.A ct was done and showed the patient had a contained abdominal aortic aneurysm rupture.As per the physician, the cause of the rupture was anatomy related due to a developed iliac aneurysm causing a type ib endoleak.The physician advised the patient had not attended any of the post implant follow ups after initial aaa treatment.The physician elected to treat the patient by occluding the right common iliac artery with an amplatz plug and implanting two endurant stent grafts (b)(4) and (b)(4) to exclude the right common iliac artery and ruptured area.The patient's blood pressure was stabilized and the patient was walking relatively pain free the following day.No additional clinical sequelae were reported, and the patient is fine.

• Brand Name: ENDURANT II 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: 7132900
• Report Number: 9612164-2017-02025
• Device Sequence Number: 1211162
• Product Code: MIH
• UDI-Device Identifier: 00643169467446
• UDI-Public: 00643169467446
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/20/2017

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: 09/06/2017
• Device Model Number: ETLW1628C156E
• Device Catalogue Number: ETLW1628C156E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 12/20/2017
• 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: 62 YR