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

Model Number	ETLW1616C93E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Film evaluation summary the reported type ib endoleak can be confirmed from the images provided.Lack of pre-implant ct¿s did not allow for a thorough assessment of the patients pre-implant anatomy.No images were provided from the index procedure showing implantation of the device.Only two post-implant cross- sectional ct slices were received, making visualisation and appreciation of the stent grafts in-vivo configuration difficult.It is possible that disease progression (with observed aneurysm enlargement) and the reported tortuous patient anatomy in the iliac arteries may have contributed to the event.In addition, it is possible that lack of adequate distal seal zone length during the implant procedure to compensate for this anatomy may have been a factor.From the images received, the distal seal zone cannot be adequately assessed.Analysis of the returned still ct¿s did not reveal any out of specification stent graft integrity issues.If information is provided in the future, a supplemental report will be issued.
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 110mm abdominal aortic aneurysm.It was reported that the patient was lost to follow up post the index procedure.The patient presented emergently with bowel issues related to the patient¿s colostomy and ct six years and five months later showed a type ib endoleak of the right iliac limb.An additional endurant ii stent graft limb etlw1620c82e was implanted to resolve the endoleak.As per the physician, the cause of the endoleak was due to the patient¿s anatomy.The right common iliac artery was very tortuous and the original limb was a couple of centimeters short of the hypogastric.No additional clinical sequelae were reported and the patient is fine.

• 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: 9744002
• Report Number: 9612164-2020-00847
• Device Sequence Number: 1974076
• Product Code: MIH
• UDI-Device Identifier: 00613994991584
• UDI-Public: 00613994991584
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/23/2020

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: 06/05/2015
• Device Model Number: ETLW1616C93E
• Device Catalogue Number: ETLW1616C93E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 03/23/2020
• 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: 83 YR