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

Model Number	ETBF3616C145E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of medical devices - information references the main component of the system.Other relevant device(s) are: product id: etlw1616c93e, serial/lot #: (b)(4), ubd: 05-mar-2017, udi#: (b)(4); product id: etlw1613c93e, serial/lot #: (b)(4), ubd: 23-feb-2017, udi#: (b)(4); product id: etlw1613c93e, serial/lot #: (b)(4), ubd: 15-jun-2017, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A heli-fx endoanchoring system was used in a patient for the endovascular treatment of a 70mm ruptured abdominal aortic aneurysm.The patient previously had an endurant ii stent graft system implanted approximately three months earlier and the endoanchors were implanted to treat neck dilation.In additional to the endoanchors, two 16x13x93 endurant ii stent graft limbs were also implanted.It was reported that a type iii endoleak of the left iliac limb at the overlap of the stent grafts was noted on a follow up ultrasound carried out on (b)(6) 2015.The endoleak resolved and the patient recovered without treatment.Per the investigator the cause of the event is not related to the procedure or device.No additional clinical sequelae were reported and the patient is fine.Medical history; tobacco (past), hypertension, hyperlipidemia, mi, pci, copd, renal disease.
Additional Manufacturer Narrative
Updated fdc after completion of investigation.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The sponsor has assessed the event as possibly related to the procedure, not related to the endoanchors and possibly related to the aneurysm.

• 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: 7905510
• Report Number: 2953200-2018-01345
• Device Sequence Number: 16567252
• Product Code: MIH
• UDI-Device Identifier: 00613994991034
• UDI-Public: 00613994991034
• 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,Followup,Followup
• Report Date (Section B): 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/04/2017
• Device Model Number: ETBF3616C145E
• Device Catalogue Number: ETBF3616C145E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 12/04/2018; 08/02/2019
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 12/06/2018; 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 105