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

Model Number	ETLW1624C124E
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/19/2019
Type of Reportable Event	Serious Injury
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.It was reported approximately 6 years post the index procedure, follow up ct demonstrated the patient's right iliac has expanded and now measures 30mm.The right iliac limb of the graft was now positioned at the aortic bifurcation, causing a type ib endoleak.Intervention was completed.The physician elected to implant 2 endurant limbs to create a distal seal extending from the graft flow divider to the right external iliac.The grafts were ballooned and final angio confirmed the endoleak has resolved.Per the physician the cause of the event is anatomy related due to disease progression.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Correction: it was reported approximately 5 years post the index procedure, follow up ct demonstrated the patient's right iliac has expanded and now measures 30mm.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: 8645193
• Report Number: 9612164-2019-02020
• Device Sequence Number: 2091116
• Product Code: MIH
• UDI-Device Identifier: 00613994991690
• UDI-Public: 00613994991690
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2019

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: 03/05/2016
• Device Model Number: ETLW1624C124E
• Device Catalogue Number: ETLW1624C124E
• Device Lot Number: V04224634
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 05/28/2019
• Supplement Report FDA Received Date: 10/24/2019
• 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: 71 YR