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

Model Number	ETBF2516C166E
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Occlusion (1984); Pain (1994)
Date of Event	06/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information references the main component of the system.Other relevant device(s) are: etlw1624c124e sn (b)(4), expiration date: 2017-09-28, udi # (b)(4).
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm.It was reported that the patient presented emergently with leg pain.A ct scan revealed that there was a right limb occlusion and the limb had narrowed at the level of the aortic bifurcation.A procedure was performed to cannulate and declot the limb.The physician was able to pass a wire through the occlusion.They then used a fogerty catheter to pull the clot from the limb.Several passes were made and the clot was successfully removed.The right limb was then lined with a 16x24x124 endurant iliac limb and ballooning was performed.The physician then opted to reinforce both iliac limbs at the native bifurcation using 2 balloon expandable stents.An angiogram was performed and showed that both limbs were patent and the procedure was completed.It was noted that the event resolved.The physician stated that the cause of the event was due to patient anatomy; specifically, a tight native distal aortic neck.No additional clinical sequelae were reported and the patient is fine.

• 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: 6688523
• Report Number: 2953200-2017-01080
• Device Sequence Number: 13477956
• Product Code: MIH
• UDI-Device Identifier: 00613994991270
• UDI-Public: 00613994991270
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/11/2017

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: 06/21/2017
• Device Model Number: ETBF2516C166E
• Device Catalogue Number: ETBF2516C166E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2017
• Initial Report FDA Received Date: 07/05/2017
• 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: 73 YR