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

Model Number	ETBF2516C124E
Medical Device Problem Codes	Leak/Splash (1354); Device Difficult to Setup or Prepare (1487); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Films review summary: the exact cause of the limb detachment and type iiia junctional endoleak could not be determined from the films provided.The anatomy at implant and amount of limb overlap at implant is unknown, and earlier post-implant films were not provided for comparison.Review of a returned ct film report from 44 months post-implant confirmed that there was a limb disconnection and resulting type iiib endoleak between the bifurcate ipsilateral limb and the right limb extension.The maximum diameter aaa measured 63mm, the 30mm limb disconnection was located in the unsupported distal aaa sac, and the contra and ipsi limbs were crossed.It is possible that insufficient limb overlap at implant, as well as aneurysm vessel morphology changes, may have contributed to the limb disconnection.The reported limb placement difficulty occuring during implant could not be determined.Continuation of medical devices: information references the main component of the system.Other relevant device(s) are: product id: e tlw1624c82e, serial/lot #: (b)(4), ubd: 22-jan-2016, udi#: (b)(4).No intervention/treatment reported.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 61 mm diameter abdominal aortic aneurysm.It was reported that during a routine follow up ct scan performed approximately 3.5 years post index procedure, it was discovered there was a separation between the ipsilateral limb of the bifurcated device and the 16x24 limb in the right common iliac.The maximum aneurysmal diameter was 63mm.This separation caused a type 3 endoleak and the aneurysm to grow.It was reported that this separation was not evident in previous follow up.As per the physician, they had some difficulty with limb placement during the case (most distal stent ring did not open).The physician stated that there may not have been adequate overlap and that the remodeling of the aorta caused a separation.No additional clinical sequelae were reported, and the patient will be monitored.
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: 7596038
• Report Number: 2953200-2018-00834
• Device Sequence Number: 1133815
• Product Code: MIH
• UDI-Device Identifier: 00613994991256
• UDI-Public: 00613994991256
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup,Followup
• Report Date (Section B): 06/18/2018

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: 07/17/2016
• Device Model Number: ETBF2516C124E
• Device Catalogue Number: ETBF2516C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 05/22/2018; 05/22/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 06/13/2018; 06/18/2018
• 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: Other
• Patient Age: 63 YR