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

Model Number	ETBF2516C124E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	10/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: product id: etlw1624c93e, serial/lot #: (b)(4), ubd: 19-sep-2015, udi#: (b)(4).Product id: etlw1624c124e, serial/lot #: (b)(4), ubd: 06-apr-2016, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii bifurcate stent graft system was implanted in the endovascular treatment of a unknown sized abdominal aortic aneurysm.It was reported that the patient presented emergently over six years later with a ruptured aneurysm.The patient was brought to the or where it was verified that the graft's contralateral limb had separated from the main body bifurcate.The left internal iliac artery was coiled off and the contralateral limb was repaired with a 16x16x156 limb and extended into the left external artery with a 16x16x124 limb.The ipsilateral right limb was also found to have a type iiia endoleak at the junction of the ipsilateral limb of the main body and the existing limb.A 16x28x124 limb was used to repair this endoleak and the rupture was contained.As per the physician the cause of the event was anatomy & natural changes in the aneurysm sac.The patients lack of follow-up was also noted.No additional clinical sequelae were provided 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 ; IE
• MDR Report Key: 10755336
• Report Number: 9612164-2020-04140
• Device Sequence Number: 13715176
• Product Code: MIH
• UDI-Device Identifier: 00613994991256
• UDI-Public: 00613994991256
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/29/2020

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: 03/18/2016
• Device Model Number: ETBF2516C124E
• Device Catalogue Number: ETBF2516C124E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 10/29/2020
• 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: 79 YR