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

Model Number	ETLW1613C156E
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	05/08/2020
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 implanted in the patient for an unknown endovascular treatment.It was reported that a type ib endoleak was observed on an unknown date.An endurant ii limb was intended to be implanted in the endovascular revision treatment for the type ib endoleak just over eleven years post the index procedure.It was reported that during the procedure, the right common iliac was very tortuous and the device could not advance.The tip of the device (delivery system) ended up getting bent due to the difficulty positioning the device.A replacement device was then implanted with no reported issues.As per the physician the cause of the event is anatomy and noted it to be tortuous.No additional clinical sequelae were provided 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 ; IE
• MDR Report Key: 10064854
• Report Number: 9612164-2020-01897
• Device Sequence Number: 776866
• Product Code: MIH
• UDI-Device Identifier: 00643169467583
• UDI-Public: 00643169467583
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/18/2020

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: 05/28/2021
• Device Model Number: ETLW1613C156E
• Device Catalogue Number: ETLW1613C156E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 05/18/2020
• 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: 80 YR