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

Model Number	ETLW1610C199E
Medical Device Problem Codes	Difficult to Insert (1316); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2019
Type of Reportable Event	Malfunction
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 planned to be implanted in a patient for the endovascular treatment of an 67mm abdominal aortic aneurysm.It was reported during the index procedure when the physician attempted to insert the device into the patient resistance was encountered.The device was removed and it was observed that the graft cover was separated from the tip of the device causing a transition.The physician attempted to insert the device again but was met with the same resistance.A new endurant device was opened and implanted without any issues.Per the physician the cause of the event is undetermined.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Additional information device evaluation summary: kinks were observed along the graft cover 2.2mm, 2.7mm,3.5mm and 14.8mm from the graft cover tip.A gap of 1.5mm (fail) was observed between the taper tip and graft cover tip; specification is 0.5mm.The tip material was raised and flared indicating it may have been stubbed during advancement.Scratches were visible along the taper tip.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The resistance was encountered when inserting the device into the femoral artery.The femoral artery was noted as 8.5mm in diameter and noted as disease free.A sheath was not used when inserting the endurant device.

• 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: 8244151
• Report Number: 2953200-2019-00100
• Device Sequence Number: 2434674
• Product Code: MIH
• UDI-Device Identifier: 00643169467620
• UDI-Public: 00643169467620
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/24/2020
• Device Model Number: ETLW1610C199E
• Device Catalogue Number: ETLW1610C199E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1