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

Model Number	ETLW1620C93E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/05/2020
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 iis stent graft system was implanted in a patient for the endovascular treatment of a 56mm ruptured abdominal aortic aneurysm.The stent graft limb etlw1620c93e was implanted on the right side.Post-operative ct had shown what appeared to be a type ii endoleak from bilateral lumbar arteries.It was reported that while the patients initially stabilised and back pain was improving, the patient¿s pain began to worsen the day after the index procedure.The patient was brought to the or where the retroperitoneum was exposed.The right internal iliac artery was ligated, and the stent graft limb etlw1610c156e was implanted to extend to the right external iliac artery through a right femoral cutdown.It was reported that the patient had a dilated distal right common iliac, but seal was achieved during the procedure.Thrombin was also injected in the aneurysm sac bilaterally to promote thrombosis of the lumbar arteries and the procedure was then completed.As per the physician, the cause of the event was the dilated distal right common iliac and bilateral lumbar arteries.No additional clinical sequelae were reported, and the patient is fine.
Additional Manufacturer Narrative
Additional information: it was confirmed there was no type ib endoleak observed in the right stent graft limb.The extension to external iliac was performed due to disease state and to exclude the disease in the right common iliac.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: 10032115
• Report Number: 9612164-2020-01803
• Device Sequence Number: 3116667
• Product Code: MIH
• UDI-Device Identifier: 00643169467514
• UDI-Public: 00643169467514
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2020

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: 11/27/2021
• Device Model Number: ETLW1620C93E
• Device Catalogue Number: ETLW1620C93E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/05/2020
• Supplement Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 05/07/2020
• Supplement Report FDA Received Date: 06/03/2020
• 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: 64 YR