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

Model Number	ENBF2516C166E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Pain (1994)
Date of Event	07/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information references the main component of the system.Other relevant device(s) are: (catalog number enlw1616c124e, serial number (b)(4), use by date 2013-06-16 and upn# (b)(4) and and catalog number etcf2828c49e, serial number (b)(4), use by date 2016-10-29 and upn# (b)(4) and catalog number enlw1613c93e, serial number unknown, use by date unknown and upn# unknown).
Event or Problem Description
An endurant stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm with additional limbs (23x13x145 and 16x13x93) implanted.The patient¿s aaa has grown from less than 3cm to 5cm.A secondary intervention was performed and an endurant ii cuff, with heli-fx endoanchors, were implanted.It was reported that the patient had chest pain and was admitted for what was thought to be a myocardial infarction.A ct scan was done of the abdomen and it was determined that the patient had an ivc filter that has stuck the ipsilateral limb of the stent graft on the right side.In addition, there also appears to be a distal type i endoleak.The physician, the cause of the type ib endoleak was due to anatomy changes and possibly from the ivc filter sticking in the ipsilateral limb of the stent graft on the right side.No additional clinical sequelae were reported and the patient is being monitored by their physician.
Additional Manufacturer Narrative
Film evaluation summary: the cause of the events could not be determined from the films provided.The anatomy at implant is unknown, and earlier post-implant films were not available for review and comparison.Ct¿s returned from 6 years post-implant revealed that an endurant stent graft system had been implanted in the patient.Contrast images were viewable only from the thoracic aorta distally down to the mid-aortic body of the bifurcate; only non-contrast films were seen from the majority of the infrarenal aorta and aaa device.Along the right side of the aaa just distal to the level of the flow divider, a section of the implanted ivc filter was seen positioned along, and possibly had penetrated within, the posterior side of the bifurcate ipsilateral/right limb.No endoleak could be verified from these non-contrast studies.The cause of the possible ivc filter penetration (and potential type iii fabric endoleak) could not be determined.It is possible that aneurysm morphology changes may have contributed.The reported distal type i endoleak also could not be determined/assessed, and may have also been caused the ivc filter, morphology changes, and disease progression (neck dilatation).If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6840974
• Report Number: 2953200-2017-01391
• Device Sequence Number: 11123922
• Product Code: MIH
• UDI-Device Identifier: 00613994762221
• UDI-Public: 00613994762221
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2013
• Device Model Number: ENBF2516C166E
• Device Catalogue Number: ENBF2516C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Initial Date Received by Manufacturer: 08/10/2017
• Supplement Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 09/04/2017
• Supplement Report FDA Received Date: 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR