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

Model Number	ETBF3616C145E
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Pain (1994)
Date of Event	05/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 100mm abdominal aortic aneurysm.It was reported that the patient presented emergently approximately five years later with hypertension and abdominal pain.It was reported that there appeared to be appeared to be a type ia endoleak and it appeared the suprarenal fixation was not attached to the stent graft fabric.A secondary procedure was carried out the next day.An endurant ii cuff was implanted up to the level of the renal arteries.Angiogram showed that there still appeared to be a type ia endoleak so 10 endoanchors were also implanted and another angiogram showed that the endoleak appeared to be resolved.As per the physician, the cause of the event cannot be determined.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Product analysis conclusion; the suprarenal detachment from the bifurcate and resulting stent graft migration and endoleak were confirmed; however the exact cause could not be determined from the returned films.Lack of pre-implant ct¿s did not allow for a thorough assessment of the pre-implant anatomy.Contrast observed within the proximal aortic neck appeared most likely to be due to a type ia endoleak.A type iiia junctional endoleak seems unlikely as there appeared to be sufficient component overlap.It is possible that disease progression due to neck dilatation may have contributed to the suprarenal stent detachment.Lack of stent graft proximal neck radial support caused by neck dilatation may have allowed increased loading of the graft fabric and/or sutures at the suprarenal stent to bifurcate fabric attachment, with eventual failure of the graft fabric/sutures and resulting distal migration of the bifurcate and proximal endoleak.The proximal portion of the suprarenal stents appeared well opposed to the aortic wall, and no clear suprarenal or aortic body stent fractures were observed.Additional information received: it was reported that when the patient returned for follow up, the aneurysm diameter had grown to 120mm with the type ia endoleak still persisting.Intervention was performed six weeks post the secondary procedure, where endoanchors were additionally implanted, it was reported this did not resolve the endoleak.No additional clinical sequelae were reported and the patient will be monitored.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: 10078300
• Report Number: 9612164-2020-01933
• Device Sequence Number: 3184508
• Product Code: MIH
• UDI-Device Identifier: 00613994991034
• UDI-Public: 00613994991034
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2020

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: 09/28/2016
• Device Model Number: ETBF3616C145E
• Device Catalogue Number: ETBF3616C145E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2020
• Initial Date Received by Manufacturer: 05/14/2020
• Supplement Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 05/21/2020
• Supplement Report FDA Received Date: 07/29/2020
• 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: 69 YR