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

Model Number ENBF2813C145EE

Device Problem Leak/Splash (1354)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Hypovolemic Shock (1917); Shock (2072); Multiple Organ Failure (3261)

Event Date 02/28/2020

Event Type  Death  

Manufacturer Narrative

Other relevant device(s) are: product id: enlw1624c80ee, serial/lot #: (b)(4), ubd: 31-aug-2012, udi#: (b)(4); product id: enlw1620c120ee, serial/lot #: (b)(4), ubd: 07-sep-2012, udi#: (b)(4); product id: enew2020c80ee, serial/lot #: (b)(4), ubd: 04-jul-2012, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant bifurcate stent graft system was implanted in an unknown endovascular treatment.It was reported that the patient presented emergently 9 years and 4 months later in deep shock.A cta was performed which had the conclusion that there was active retroperitoneal bleeding based on a undetermined type iii endoleak (right side just cranial of the bifurcation of the prosthesis).The aneurysm ruptured due to the type iii endoleak.The patient was emergently brought to or in shock (tension of 40mmhg, temperature 35 degrees).An aorto-uni-iliac prosthesis was implanted to the right leg and a fem-fem crossover to the left leg was performed.During that night the patient was tachycardiac and hypotensive and in discomfort.They became increasingly more hemodynamically unstable.It was then reported that because of this, all treatment and medication was stopped and the patient was extubated.The patient expired shortly after the treatment ceasing.The sponsor and the site assessed the event as related to the endurant device and not related to the procedure.No additional clinical sequelae were provided and the patient is expired.

Manufacturer Narrative

It was confirmed on both the cta and angiography that the endoleak appeared to be a type iiib (tear) of the bifurcate main body stent graft.The patient died of multiorgan failure after deep hypovolemic shock pre-operatively.The cause of the event can not be determined.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Sponsor assessed the rupture to be related to the device and related to the procedure.Site assessed type iii endoleak to be related to the device and not related to the procedure.Sponsor assessed type iii endoleak to be related to the device and not related to the procedure.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 BIFURCATED STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9805091
• MDR Text Key: 182533279
• Report Number: 9612164-2020-01073
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/23/2020

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: 09/27/2012
• Device Model Number: ENBF2813C145EE
• Device Catalogue Number: ENBF2813C145EE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/05/2020
• Initial Date FDA Received: 03/09/2020
• Supplement Dates Manufacturer Received: 04/01/2020; 06/25/2020
• Supplement Dates FDA Received: 04/27/2020; 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 110