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

Model Number	ENLW1624C93E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	10/31/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: enbf3620c145e , s/n: (b)(4); use by date: 2014-04-03; upn # (b)(4), medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the if information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Heli-fx endoanchors were implanted in an endurant stent graft during the endovascular treatment of an 61mm abdominal aortic aneurysm.The aortic neck length was observed to be 20mm in length, with an aortic diameter of 17.67mm at 1mm, 16.8mm at 10mm, 17.67 at 15mm and 18.39 at 20mm below the lowest renal artery.The proximal aortic neck angle was 80 degrees.Three endoanchors were implanted due to a concern for late failure.It was reported that approximately 6 years post index procedure, the patient experienced pulmonary issues, specifically hypoxemia.The event relationship was determined to be uncertain.The patient was given oxygen at home as treatment.The event was resolved.No additional clinical sequelae were reported.

• Brand Name: ENDURANT 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: 7498087
• Report Number: 2953200-2018-00676
• Device Sequence Number: 16573232
• Product Code: MIH
• UDI-Device Identifier: 00613994761897
• UDI-Public: 00613994761897
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/09/2018

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: 04/19/2014
• Device Model Number: ENLW1624C93E
• Device Catalogue Number: ENLW1624C93E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 05/09/2018
• 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
• Patient Weight: 55