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

Model Number	ENBF3216C166E
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Pain (1994); Rupture (2208)
Date of Event	07/20/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
An endurant ii stent graft system was inserted in a in a patient for the endovascular treatment of a 58.65mm diameter abdominal aortic aneurysm.It was reported that the patient presented emergently in the emergency room on with abdominal/back pain.A ruptured infra-renal aneurysm was discovered via ct scan.The patient was transferred directly into surgery where the physician explanted the endurant stent graft.Per the physician the cause of the event was due to persistent type ii endoleak resulting in proximal neck dilatation leading to proximal graft migration of 5-10mm and an eventual type 1a endoleak which was noted at the time of explant surgery.No additional clinical sequelae were reported and the patient is fine.

• Brand Name: ENDURANT BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6799815
• Report Number: 2953200-2017-01305
• Device Sequence Number: 16529075
• Product Code: MIH
• UDI-Device Identifier: 00613994762429
• UDI-Public: 00613994762429
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/24/2017

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: 06/06/2013
• Device Model Number: ENBF3216C166E
• Device Catalogue Number: ENBF3216C166E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 08/17/2017
• 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: 84 YR