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

Model Number	ETBF3616C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2020
Type of Reportable Event	Malfunction
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, and heli-fx endo-anchors were implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm.It was reported approximately 7 years post the index procedure follow up ct angiogram identified a type ia endoleak.A reliant balloon was used to balloon, however, the endoleak persisted.Per the physician, the cause of the endoleak is anatomy related likely due to neck dilation.No additional clinical sequelae were reported, and the patient will be monitored.
Additional Manufacturer Narrative
Film evaluation summary the reported type ia endoleak could not be confirmed on the film provided but also could not be ruled out.Lack of additional returned angiography images or videos showing the endoleak, which may have included possible endoleak interrogation, did not permit a more comprehensive analysis of the endoleak source/cause.Post-implant ct¿s for assessment of the endoleak were also not provided.It is likely that disease progression over the 7 years of implantation, with the reported neck dilatation, may have been a factor in the reported endoleak.It is unknown if the lack of expansion of the suprarenal stents, leading to decreased stent graft lumen proximally, occurred in conjunction with the disease progression and may have contributed to the occurrence of a proximal endoleak.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 ; EI
• MDR Report Key: 10926587
• Report Number: 9612164-2020-04683
• Device Sequence Number: 4330036
• Product Code: MIH
• UDI-Device Identifier: 00613994991041
• UDI-Public: 00613994991041
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/02/2015
• Device Model Number: ETBF3616C166E
• Device Catalogue Number: ETBF3616C166E
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/18/2020
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 12/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR