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

Model Number	ETLW1616C82E
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2017
Type of Reportable Event	Malfunction
Event or Problem Description
An endurant ii stent graft system was implanted in the patient for endovascular treatment of an abdominal aortic aneurysm.It was reported that during the index procedure, the delivery system was inserted into the patient and positioned at the intended location.The proximal end of the stent graft started to deploy without rotating the external slider to retract the graft cover.As a result, the physician was unable to reposition the stent graft.The stent graft was implanted to the intended location despite that it deployed without rotating the external slider, because the delivery system was already at the intended location prior to deployment.The patient did not experience any adverse events.The physician remodeled the stent graft with a balloon and the procedure was successfully completed.No clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Corrected information: sex.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: 6403585
• Report Number: 2953200-2017-00388
• Device Sequence Number: 13696925
• Product Code: MIH
• UDI-Device Identifier: 00643169467576
• UDI-Public: 00643169467576
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2017

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: 06/22/2018
• Device Model Number: ETLW1616C82E
• Device Catalogue Number: ETLW1616C82E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/17/2017
• Supplement Date Received by Manufacturer: 02/17/2017
• Initial Report FDA Received Date: 03/14/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR