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

Model Number	ETLW1624C124E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis conclusion; the reported iliac artery enlargement was confirmed on the films provided; however, the cause of the event could not be determined.Complete recent ct¿s were not available for review; therefore, a thorough assessment of the patient¿s anatomy and stent graft in-vivo configuration could not be performed.Lack of pre-implant ct¿s did not allow for a thorough assessment of the pre-implant anatomy.It is considered that aneurysm morphology changes due to disease progression over the course of implantation of the device may have been a factor in the observed event but this could not be confirmed.Concomitant medical products: other relevant device(s) are: product id: e tlw1624c124e, serial/lot #: (b)(4), ubd: 13-sep-2018, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Endurant ii stent grafts were implanted during an endovascular procedure for the treatment of a 50mm abdominal aortic aneurysm.It was reported from a ct from an unknown date that the left common iliac artery has dilated to approximately 25mm and the right common iliac artery has  dilated to approximately 36 mm distal to the existing stent graft limb.It appears that the existing grafts are in place with no issues involving the graphs.A secondary procedure was performed.Initially imaging was interrogated and both proximal and bilateral distal seals zones were an alyzed.Proximally the stent graft looked good with no type ia endoleak.As expected the left common iliac stent exists approximately 1 cm above the hypogastric on that side.The seal on the left side was found to have no problem and no reason to extend or treat the left limb as what was previously anticipated.Due to the dilated segment of the distal common iliac artery on the right side the physician decided to coil the right hypogastric artery and implant a plug.An extension limb was placed in the existing graft on the right side and created a seal across the right type of gastric and into the right external iliac artery.The procedure went well and exactly as expected.The patient went back to a step down icu unit and was this charged later in the day.As per the physician the cause of the dilation cannot be determined.  no additional clinical sequelae was provided and the patient is fine.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13692393
• Report Number: 9612164-2022-00901
• Device Sequence Number: 14776176
• Product Code: MIH
• UDI-Device Identifier: 00643169467507
• UDI-Public: 00643169467507
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/08/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2018
• Device Model Number: ETLW1624C124E
• Device Catalogue Number: ETLW1624C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male