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

Model Number	ETLW1620C93E
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As per the physician the cause of the right limb migration is anatomy, the limb migrated due to the type ii endoleak from a patent lumbar artery.If information is provided in the future, a supplemental report will be issued.
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 the endovascular treatment of a unknown size aortic abdominal aneurysm on (b)(6) 2015.It was reported that the left limb (etlw1616c93e) had migrated on an unknown date eight months post the index procedure, and was treated at the time and extended with an endurant ii limb etlw1610c199e, which resolved the event.As per the physician the cause of this event is anatomy.It was reported that when the patient returned for follow up four years and nine months post index procedure, a ct showed the right limb (etlw1620c93e) has migrated into the aneurysm sac as a result of a apparent type ib endoleak.As per the physician the cause of the right limb migration is anatomy, the limb migrated due to the type ib endoleak from a patent lumbar artery.The patient was noted to have a short (25mm) common iliac artery.It was reported that the patient was treated with a limb extension on the right side.The stent graft limb etlw1628c124e was used to extend the hypogastric and final angio showed no type ib endoleak.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Additional information: it was reported that the patient was treated with a limb extension on the right side on (b)(6) 2020.The stent graft limb etlw1628c124e was used to extend the hypogastric and final angio showed no type ib endoleak film analysis: the reported right limb migration and resulting distal type i endoleak was confirmed.The exact cause cannot be determined.The anatomy at implant is unknown and earlier post-implant ct¿s were not returned for comparison.The right limb od which had pulled out of the right common iliac measured 22mm, and the origin of the right common iliac artery measured ~29mm in diameter; therefore, disease progression (vessel dilatation) may have been a likely contributor.Disease progression and the reported short (25mm) common iliac artery may have also led to the left limb migration and resulting distal type ib endoleak.The reported type ii endoleak may have also contributed to the events.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: 9685694
• Report Number: 9612164-2020-00622
• Device Sequence Number: 2401822
• Product Code: MIH
• UDI-Device Identifier: 00613994991638
• UDI-Public: 00613994991638
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/07/2016
• Device Model Number: ETLW1620C93E
• Device Catalogue Number: ETLW1620C93E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 01/15/2020; 02/11/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 02/12/2020; 02/28/2020
• 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: 77 YR