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

Model Number	ETBF3620C145E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	08/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: from the single still angio image returned the reported dissection was confirmed.However, the cause could not be determined, and analysis of the returned films did not reveal any stent graft characteristics that could explain the reported event.It appears that the dissection was procedure related; likely caused by manipulation of the devices used during the index procedure.The dissection and the patient¿s pre-existing stenosis and calcification in the right common femoral artery, may have also contributed to the reported poor distal outflow and loss of pulse.A good faith effort will be made to obtain the applicable information relevant to the report.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 abdominal aortic aneurysm.There was a stenosis and calcification in the right common femoral artery that was present prior to the procedure.It was reported that a dissection occurred in the right external iliac artery after the placement of the stent graft.The dissection was not flow limiting at the time of implant so the physician decided not to treat the dissection.During the patient¿s recovery, they lost pulse in their right lower extremity.The patient was brought back to the operating room and the physician placed several stents from another manufacturer in the right common iliac.This reportedly repaired the dissection.An 80% stenosis was also treated in the right common femoral artery with a balloon.The right common femoral also reportedly had a severe calcium deposit that was treated with a patch graft.It was noted that the event was resolved.The physician stated that the cause of the loss of pulse was due to the dissection of the right external iliac artery and diseased outflow.The physician also noted that the stent graft did not cause the loss of pulse in the right common femoral artery.The physician determined that the dissection was caused by manipulation of the devices (catheters, wires, etc.) used during the index procedure.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: 6830365
• Report Number: 2953200-2017-01362
• Device Sequence Number: 852972
• Product Code: MIH
• UDI-Device Identifier: 00613994991058
• UDI-Public: 00613994991058
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/05/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2019
• Device Model Number: ETBF3620C145E
• Device Catalogue Number: ETBF3620C145E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2017
• Initial Report FDA Received Date: 08/30/2017
• 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; Disability
• Patient Age: 84 YR