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

Model Number	ETBF3220C145E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	12/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: etcf3232c49e, serial/lot #: (b)(4), ubd: 21-aug-2015, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system and endoanchors were implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm.It was reported the patient presented emergently approximately 5 years post the index procedure.A ct revealed aaa rupture from a type ia endoleak.Intervention was completed with an endurant aortic cuff and endoanchors implanted in an attempt to resolve the event.Ballooning was then completed however this did not resolve the endoleak or seal the rupture successfully.The physician then converted to an open procedure and the patient status was reported as stable post procedure.Per the physician the cause of the event is related to a type ia endoleak (due to loss of seal).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: 8155252
• Report Number: 2953200-2018-01678
• Device Sequence Number: 16567541
• Product Code: MIH
• UDI-Device Identifier: 00613994991010
• UDI-Public: 00613994991010
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2019

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: 08/20/2015
• Device Model Number: ETBF3220C145E
• Device Catalogue Number: ETBF3220C145E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 03/28/2019
• 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