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

Catalog Number	ETLW1628C124E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/11/2019
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 stent graft system was implanted into the patient for the endovascular treatment of an abdominal aorta aneurysm on an unknown date at an unknown location.Vessel morphology at the time of implant is unknown.The patient arrived via helicopter to trauma center.The ct revealed that the patient had an endurant stent graft system implanted with a type iii endoleak, separation between the contralateral 16x28 iliac limb and the 28x28x82 extension iliac limb.The physician implanted an endurant 16x18x124 iliac limb stent graft re-lining existing stent grafts at contra gate to contra limb overlap.The type iii endoleak, separation was resolved.It further was reported that a ct showed a type iii separation endoleak on the left side on an unknown date and angiogram confirmed the endoleak.The etlw1628c124e appeared to have separated from the distal extension.Intervention was performed with the addition of an endurant extension to bridge the separation and the endoleak was not observed again.The cause of the event is related to anatomy as per the physician due to the tortuosity of the left iliac.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Additional information: it was reported that ct approximately 4 years and 7 months post implantation of the stent graft limb (b)(4) showed a suspected type iiia endoleak.A re-intervention procedure was carried out approximately 3 and a half weeks later and the type iiiia endoleak was confirmed by angio.It was reported that the endoleak occurred between the original left stent graft limb (b)(4) and the extension limb (b)(4) that had been later added.A stent graft limb e(b)(4) was used to reline the stent graft from the flow divider to the internal iliac artery and the event was reported to be resolved.As per the physician, the cause of the event cannot be undetermined.No additional clinical sequelae were reported and the patient is fine.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: 8730900
• Report Number: 9612164-2019-02517
• Device Sequence Number: 19253725
• Product Code: MIH
• UDI-Device Identifier: 00613994991348
• UDI-Public: 00613994991348
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2019

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: 08/25/2016
• Device Catalogue Number: ETLW1628C124E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 10/31/2019
• 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: 75 YR