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

Model Number	ETLW1616C82E
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2019
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 aneurx stent graft system was used for the endovascular treatment of an aortic abdominal aneurysm.The aneurysm has a current size of 120mm.It was reported during a follow up ct 12 years and 7 months later, that a type ib endoleak was identified at the distal part of the right iliac limb.A secondary procedure was carried out for the treatment of the endoleak.An angiogram preformed at the beginning of the procedure confirmed the presence of the endoleak in a very tortuous iliac artery.The physician treated this by placing an endurant ii limb extending from inside the aneurx limb into the external iliac covering the right hypogastric artery.It was reported that while attempting to place the endurant ii limb the tortuosity of thevessel caused the limb to kink in the delivery system.The limb would not advance into the previous graft due to the kink.As well it was reported that this device was then replaced by another mdt endurant ii limb.A 14fr sheath was first put into the iliac reaching up in to previous graft and this helped the new limb navigate the tortuous vessel.It was successfully delivered and then ballooned.It was reported that on final angiogram that the endoleak had resolved.The procedure was then completed.The cause of the event as per the physician was related to patient¿s tortuous iliac artery.Additionally, the cause of the endoleak was reported to be due to iliac dilatation.No additional clinical sequelae were reported, and the patient is fine.

• 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: 9395033
• Report Number: 9612164-2019-04966
• Device Sequence Number: 11451090
• Product Code: MIH
• UDI-Device Identifier: 00643169467576
• UDI-Public: 00643169467576
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/02/2019

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: 01/16/2020
• Device Model Number: ETLW1616C82E
• Device Catalogue Number: ETLW1616C82E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 12/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1