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

Model Number	ETLW1616C156E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: etlw1613c93e, serial/lot #: (b)(4), ubd: 14-aug-2020, 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 140mm abdominal aortic aneurysm.It was reported that an endurant stent graft system was used to reline a previously implanted non mdt stent graft to treat a type iiib endoleak.Two endurant ii limbs (etlw1616c156e and etlw1613c93e) were implanted on the right side.The etlw1613c93e was implanted as an extension inside the etlw1616c156e.The relining treatment appeared successfully as per the imaging during and post procedure.It was noted that a follow up ct three days post implant showed that the right contra limb (etlw1616c156e) was not within the gate of the main body and this caused the previous endoleak to continue.The patient was transferred to another facility for treatment of a gi bleed.It was noted that the patient has not and will not receive treatment.As per the physician, the cause of the event cannot be determined.No additional clinical sequelae were reported and the patient will be monitored.

• 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: 8439891
• Report Number: 2953200-2019-00394
• Device Sequence Number: 1063022
• Product Code: MIH
• UDI-Device Identifier: 00643169467668
• UDI-Public: 00643169467668
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 03/21/2019

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: 11/28/2020
• Device Model Number: ETLW1616C156E
• Device Catalogue Number: ETLW1616C156E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 104