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

Model Number	ETBF2316C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event date unknown.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 71 mm diameter abdominal aortic aneurysm.It was reported that the patient returned for follow up on an unknown date.The main body of the stent graft was explanted because of a suspected type iv endoleak.It was noted that both limbs and the supra renal stent were left in place.It was noted that the explantation resolved the endoleak and that the product will be replaced in the future by an mdt product.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
Device evaluation summary; from the examination of the returned device and clinical information provided, the cause of the aaa expansion could not be determined.No stent graft integrity issues were observed from the single returned device, and the explant analysis did not reveal any stent graft characteristics that could explain the reported increasing aaa size.The cause of the reported type iv endoleak or the source of any other endoleak which may have led to the aaa expansion could not be determined.Lack of films did not allow for a review of the patient¿s anatomy, stent graft in-vivo configuration during the implant duration, as well an assessment of any potential endoleak.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7233617
• Report Number: 2953200-2018-00169
• Device Sequence Number: 16623798
• Product Code: MIH
• UDI-Device Identifier: 00613994991218
• UDI-Public: 00613994991218
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2018

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: 09/21/2017
• Device Model Number: ETBF2316C166E
• Device Catalogue Number: ETBF2316C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Initial Date Received by Manufacturer: 01/10/2018
• Supplement Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 02/01/2018
• Supplement Report FDA Received Date: 05/01/2018
• 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: Required Intervention