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

Model Number	ETTF3232C70E
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/04/2019
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 anuerx stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm.Both the yri rx16115 and yrecx1655 stent graft limbs were placed on the contralateral side.It was reported that the patient presented emergently approximately fifteen years later and a ct study showed migration of the bifurcated stent graft in to the aneurysm sac and a type ia endoleak.The current aneurysm size is a 75 mm.As per the physician, the cause of the event cannot be determined.A secondary intervention procedure was carried out the following day and two endurant aortic extensions were implanted.It was reported that the aortic extension ettf3232c70e was inadvertently deployed below the flow divider and subsequently obstructed flow down the contralateral limb.A fem-fem bypass was carried out to restore flow to the contralateral limb.As per the physician, one of the contributing factors was that the c-arm was unable to "tilt" or "angle" into the cranial position as a result of the base arm hitting the bottom of the base stand of the or table.No additional clinical sequelae were reported and the patient is fine.

• Brand Name: ENDURANT II EXTENSION STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8739131
• Report Number: 9612164-2019-02558
• Device Sequence Number: 2296623
• Product Code: MIH
• UDI-Device Identifier: 00613994991508
• UDI-Public: 00613994991508
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/27/2019

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: 12/21/2019
• Device Model Number: ETTF3232C70E
• Device Catalogue Number: ETTF3232C70E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 06/27/2019
• 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