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

Model Number	ETBF3616C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	09/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: product id: etlw1616c93e, serial/lot #: (b)(4), ubd: 01-sep-2017, udi #: (b)(4); product id: etlw1616c124e, serial/lot #: (b)(4), ubd: 02-sep-2017, udi #: (b)(4); product id: etlw1616c82e, serial/lot #: (b)(4), ubd: 14-sep-2017, udi #: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii aortic cuff was implanted in a patient for the endovascular treatment of an unknown size abdominal aortic aneurysm.The current proximal aortic neck diameter measures 32 mm.It was reported approximately 4 years post the index procedure the patient presented emergently with back pain.Ct identified an enlarging aaa and a suspected type ia/ib endoleak.Intervention was completed and the physician elected to implant a 36 mm aortic cuff, 5 endoanchors and a 20 mm limb extension to the rci with resolution of the endoleak confirmed.Per the physician the cause of the event is undetermined.No additional clinical sequelae were reported and the patient is fine.

• 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: 9081470
• Report Number: 9612164-2019-03967
• Device Sequence Number: 2623236
• Product Code: MIH
• UDI-Device Identifier: 00613994991041
• UDI-Public: 00613994991041
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2017
• Device Model Number: ETBF3616C166E
• Device Catalogue Number: ETBF3616C166E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 09/18/2019
• 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: 83 YR