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

Model Number	ETLW1620C82E
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2019
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 limb was planned to be implanted in a patient for the endovascular treatment of an aortic iliac aneurysm.It was reported that the device was prepped on the back table to get ready for implant.It was reported that the stiff wire would not pass through the wire lumen of the delivery system.The device was not placed in the patient.Another stent graft limb etlw1620c93e was used instead.As per the physician, the event was device related.No additional clinical sequelae were reported, and the patient is fine.
Additional Manufacturer Narrative
Device evaluation summary a kink was observed on the graft cover at the end of the stent stop 8.4cm from the tip.Damage was visible to the inner spiral underneath the graft cover bond.A 0.035-inch guidewire was loaded via the taper tip and advanced along the lumen.A blockage was observed at the kink site at the end of the stent stop.The guidewire was inserted via the luer and advanced; a blockage was observed at the damage section of the spiral inner/graft cover bond.On deployment of the graft a kink was visible on the spiral inner at the stent stop.The handle was disassembled, and the graft cover removed.Damage to the spiral inner was clearly visible at the graft cover bond area.The reported insertion difficulties were confirmed through analysis.If information is provided in the future, a supplemental report will be issued.

• 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: 9444154
• Report Number: 9612164-2019-05080
• Device Sequence Number: 16800917
• Product Code: MIH
• UDI-Device Identifier: 00643169467521
• UDI-Public: 00643169467521
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2020

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: 10/07/2020
• Device Model Number: ETLW1620C82E
• Device Catalogue Number: ETLW1620C82E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 03/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR