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

Model Number	ETLW1624C156E
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2019
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 implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm of unknown size.It was reported that ct 3 years later showed that the left limb had migrated back.As per the physician, the cause of the event was anatomy related.No additional clinical sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
Film analysis summary: the reported left limb migration out of the left common iliac artery was confirmed.The exact cause of the migration could not be determined; the anatomy at implant is unknown and earlier post-implant films were not provided for comparison.However, this appears most likely to have been anatomy related due to disease progression with iliac artery dilatation.There was also possible vessel morphology changes as evidenced by the severe limb tortuosity of the migrated contra limb, and moderate infrarenal neck angulation.It is also likely that there was associated sac pressurization from the left limb migration as well as from the marginal distal seal on the right iliac, which may have all contributed to potential aaa expansion.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: 8670319
• Report Number: 9612164-2019-02177
• Device Sequence Number: 284619
• Product Code: MIH
• UDI-Device Identifier: 00613994991706
• UDI-Public: 00613994991706
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2019

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: 11/13/2014
• Device Model Number: ETLW1624C156E
• Device Catalogue Number: ETLW1624C156E
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/23/2019
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 06/05/2019
• Supplement Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1