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

Model Number	ETBF2816C166E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: product id: enew2020c82e, serial/lot #: (b)(4), ubd: 09-oct-2013, udi#: (b)(4); product id: enlw1620c124e, serial/lot #:(b)(4), ubd: 16-apr-2014, udi#: (b)(4); product id: etlw1616c124e, serial/lot #: (b)(4), ubd: 09-jul-2014, udi#: (b)(4).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 an abdominal aortic aneurysm.An endurant ii iliac extension stent graft limb was also implanted approximately one week later it was reported that the patient presented with an e.Coli infection and all of the patients devices were explanted and replaced with non-mdt product approximately six and a half years after the index procedure.As per the physician, the cause of the explant was due to the e.Coli infection.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II 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: 8988155
• Report Number: 9612164-2019-03863
• Device Sequence Number: 3329976
• Product Code: MIH
• UDI-Device Identifier: 00613994991133
• UDI-Public: 00613994991133
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2019

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: 10/20/2014
• Device Model Number: ETBF2816C166E
• Device Catalogue Number: ETBF2816C166E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2019
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 10/24/2019
• 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: 66 YR