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

Model Number ETLW1624C93E

Device Problem Leak/Splash (1354)

Patient Problems Pleural Effusion (2010); Insufficient Information (4580)

Event Date 12/19/2018

Event Type  Death  

Manufacturer Narrative

Concomitant medical devices: other relevant device(s) are: product id: etlw1613c156e, serial/lot #: (b)(4), ubd: 15-feb-2017, udi#: (b)(4).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A valiant navion (v08147847) stent graft was implanted in the endovascular treatment of a type ia endoleak as a endograft extension with bilateral renal artery and sma snorkeling.A endurant ii stent graft system had been implanted 3 years and 5 months previously.About 5 months post the navion implant, the patient was struggling with various endoleaks and coil embolization and glue was used as treatment.4 months later, an aortic endoleak required intervention with onyx glue.Another 8 months later, the patient has a taaa that is at an operable size.The patient underwent an open repair, a non mdt branch graft was placed while the valiant navion v08147847 was explanted.Another 6 months later, a new thoracic aortic aneurysm and thoracoabdominal aortic dissection were observed so 6 valiant navions were implanted.A ct scan was performed just over 3 months post the 6 valiant navion implants.A ct of the chest demonstrates the dimensions of the thoracic aortic aneurysm in the appearance of the endograft repair are stable.The native aneurysm measures up to 6.3 cm axially in the descending aorta.The density of the clot in the aneurysm of the descending thoracic aorta is diminished from about 22hu to 11 hu.Compared to the previous study there is new density in the aortic arch suspected to represent blood product not seen on the previous study measuring about 10 x 20 mm.This is just beyond the origin of the thoracic aortic portion of the endograft and appears to represent blood product.There is atelectasis at the left base.There is stable pleural thickening unchanged from previous.There is a small right pleural effusion and developed since previous, with compressive atelectasis.Cta of the abdomen and pelvis demonstrates stable size of the extensive aneurysm of the aorta that extends well into the pelvis along the course of the left iliac artery.The left internal iliac artery appears occluded.There is diminished density of the clot in the aneurysm compared to the previous study.There is normal opacification of the aorta, celiac artery, sma, both renal arteries, common iliac, right internal iliac.It was reported the patient expired 12 days post this ct scan due to an unknown cause.The physician does not know the cause as the patient was living out of state.No cause was reported.No additional clinical sequalae were provided and the patient is expired.

Manufacturer Narrative

Additional information received: it was reported the first time the physician saw this patient was on (b)(6) 2018, as the patient was referred to the clinic for review of the aaa and endoleak.The patient had the first repair of this endoleak at this facility on the (b)(6) 2018, where onyx was used and injected into the aneurysm sac.Follow-up on the (b)(6) 2018 showed no residual endoleak.On the (b)(6) 2018, the patient had surgery to repair a type iii endoleak.The patient was noted to have significant sac expansion since treatment of a complex infrarenal aaa.On preoperative imaging, the patient was found to have evidence of the modular pieces of the iliac branch endoprosthesis, had become separated on the internal iliac component, and thus creating a type iii endoleak.The patient had 2 non mdt stents implanted as treatment to the right internal iliac artery.Ct scan on the (b)(6) 2018, showed postsurgical changes of evar of infrarenal abdominal aortic aneurysm with persistent contrast extravasation into the proximal aneurysm sac.While no definite arterial source is visualized, findings are suggestive of a type 1a endoleak.A type 2 endoleak cannot be excluded on the study.Therefore the valiant navion (b)(6) was implanted 6 days later as treatment.No further information is available on the patients death medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15779999
• MDR Text Key: 303533911
• Report Number: 9612164-2022-04199
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169467460
• UDI-Public: 00643169467460
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2017
• Device Model Number: ETLW1624C93E
• Device Catalogue Number: ETLW1624C93E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 11/11/2022
• Supplement Dates Manufacturer Received: 11/23/2022
• Supplement Dates FDA Received: 12/14/2022
• Date Device Manufactured: 04/16/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention; Other
• Patient Age: 77 YR
• Patient Sex: Male