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

Model Number	ENEW2424C82E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/05/2018
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 stent graft system was implanted in the patient for the endovascular treatment of a 32mm abdominal aortic aneurysm on (b)(6) 2011.The proximal neck diameter was noted as 23mm and 20mm in length.A torturous external iliac artery was reported at the index procedure.It was reported that on ct completed approximately 7.5 years post index procedure, the right iliac artery had dilated beyond the size of the 24mm implanted limb extension.Intervention was carried out where the right hypo gastric artery was coiled and a 16x10 endurant limb was implanted into the external iliac artery to seal it.The event was resolved.As per the physician, the cause of the event was anatomy related where the iliac artery had dilated over time.No additional clinical sequelae were reported and the patient is fine.

• 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: 7641530
• Report Number: 2953200-2018-00900
• Device Sequence Number: 1719340
• Product Code: MIH
• UDI-Device Identifier: 00613994762139
• UDI-Public: 00613994762139
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/27/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/23/2012
• Device Model Number: ENEW2424C82E
• Device Catalogue Number: ENEW2424C82E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 06/27/2018
• 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: 84