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

Model Number	ETLW1624C124E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/18/2019
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 limb was implanted for the endovascular treatment of a 98mm abdominal aortic aneurysm.It is reported that during the index procedure a type iii endoleak was observed.This endoleak was then resolved by relining the stent graft limb etlw1624c124e with another endurant limb etlw1616c93e.As per the physician the cause of the event is due to patient anatomy, which was reported to be tortuous.No additional clinical sequelae was provided and the patient is fine.
Additional Manufacturer Narrative
Additional information:it was confirmed that a bifurcate device was implanted along with the endurant limb during the index procedure.Analysis summary: the reported endoleak seen immediately following implant could not be confirmed from the pre-implant ct¿s.Images during implant were provided; therefore, the reported event including the type or location of the endoleak could not be assessed.Post-implant ct¿s were not available for review and the stent graft in-vivo configuration could not be evaluated.Analysis of the returned films did not reveal any obvious anatomical anomalies that may have led to the reported type iii endoleak.The reported limb relining could have resolved several different endoleak types.A type iii fabric endoleak would be less likely to have occurred at index; however a type iiia junctional endoleak due to insufficient component overlap could not be ruled out.This may have been an acute type iv blush endoleak caused by fabric porosity which most likely would have self-resolved within 24 hours.Other factors such as heparin dose, outflow resistance, imaging quality, and volume of the aneurysm sac may have also contributed to this possible type iv endoleak.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The subtype of type iii endoleak is unknown.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9595123
• Report Number: 9612164-2020-00255
• Device Sequence Number: 11628333
• Product Code: MIH
• UDI-Device Identifier: 00643169467507
• UDI-Public: 00643169467507
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2020

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: 09/09/2021
• Device Model Number: ETLW1624C124E
• Device Catalogue Number: ETLW1624C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 01/17/2020; 02/21/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 02/10/2020; 03/13/2020
• 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: 81 YR