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

Model Number	ETBF2813C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: etlw1628c124e, serial/lot #: (b)(4), ubd: 04-jul-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 was implanted in a patient for the endovascular treatment of a 42mm abdominal aortic aneurysm.It was reported that the patient presented emergently approximately 6 years and 4 months post implant with increasing back and flank pain.Cta showed a type ia and type ib endoleak with significant dilation of both common iliac artery's (left cia>70mm) and expansion of the proximal aortic neck.It was confirmed that the bifurcate stent graft was not involved in the type ib endoleak.The left common iliac limb appeared to be ¿floating¿ in the common iliac space.Treatment was performed the following day and it was decided to extend bilaterally in the eia's along with coil embolization of the left internal iliac artery.Bilateral chimney graphs were also placed in both renals to facilitate extension of the coverage to the level of the sma.The endoleaks were resolved.As per the physician, the cause of the event was related to loss of the patient to follow up - loss of apposition of the stent graft, due to the dilation of the patient's vessels, that lead to the endoleaks was not seen.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film analysis the reported dilation of the proximal neck and bilateral common iliac arteries, with resulting proximal and distal type i endoleaks and expansion of the aaa, was confirmed.The exact cause could not be determined from the films returned at 75 months post-implant.The anatomy at implant was not reported, and earlier post-implant cts were not provided for comparison.However, it appears likely that disease progression, with dilatation of the proximal neck and bilateral common iliac arteries, led to the events.Likely aneurysm morphology changes as seen with the severely angulated neck may have also contributed.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: 9464963
• Report Number: 9612164-2019-05149
• Device Sequence Number: 14194765
• Product Code: MIH
• UDI-Device Identifier: 00613994991300
• UDI-Public: 00613994991300
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 01/14/2020

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: 06/27/2015
• Device Model Number: ETBF2813C166E
• Device Catalogue Number: ETBF2813C166E
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 01/14/2020
• 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: 69 YR
• Patient Weight: 78