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

Model Number ETUF3214C102EE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Multiple Organ Failure (3261)

Event Date 02/28/2020

Event Type  Death  

Manufacturer Narrative

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 (rszight 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

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.If information is provided in the future, a supplemental report will be issued.

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.

• Brand Name: ENDURANT II AUI STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 9805110
• MDR Text Key: 182533548
• Report Number: 9612164-2020-01074
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• 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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2020
• Device Model Number: ETUF3214C102EE
• Device Catalogue Number: ETUF3214C102EE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2020
• Initial Date FDA Received: 03/09/2020
• Supplement Dates Manufacturer Received: 03/17/2020; 06/25/2020
• Supplement Dates FDA Received: 04/10/2020; 07/23/2020
• Date Device Manufactured: 09/18/2018
• 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
• Patient Age: 80 YR
• Patient Weight: 110