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

Model Number	ETLW1616C82E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: etlw1620c124e, serial/lot #: (b)(4), ubd: 27-jun-2018, udi#: (b)(4); product id: etbf3216c166e, serial/lot #: (b)(4), ubd: 16-jun-2018, udi#: (b)(4).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 60 mm abdominal aortic aneurysm on (b)(6) 2016.It was reported that ct, approximately two years and eight months post the index procedure, showed continued expansion of the aneurysm with no evidence of an endoleak.Upon reaching 80mm the physician decided to expose the aorta and look for a type ii endoleak or any other issue.Upon opening the abdomen and exposing the graft the physician noticed blood seeping through the graft material at multiple areas at the flow divider and below and throughout the iliac limbs bilaterally.It was reported that the physician thought it was a type iv endoleak.It was decided to finish the exploration at this point without carrying out any intervention.It was reported that the patient presented emergently approximately three months later with pain and the physician decided at this point to carry out an intervention.The bifurcate was relined with a non-mdt aortic cuff and the limbs with non-mdt excluder limbs.It was reported that the patient responded favourably and is stable and discharged.As per the physician, the cause of the event was a type iv endoleak possibly around the sutures that sew the stents to the graft material.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Update: fdc coded added at investigation completion.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: 8914280
• Report Number: 9612164-2019-03491
• Device Sequence Number: 2000672
• Product Code: MIH
• UDI-Device Identifier: 00643169467576
• UDI-Public: 00643169467576
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2019

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: 12/20/2017
• Device Model Number: ETLW1616C82E
• Device Catalogue Number: ETLW1616C82E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 10/08/2019
• 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: 68 YR