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

Device Problems Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aneurysm (1708); Fever (1858); Gastritis (1874); Weakness (2145); Injury (2348); Malaise (2359); Blood Loss (2597); Weight Changes (2607)

Event Date 07/12/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: endurant stent graft; s/n: unknown; use by date: unknown; upn # unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant ii stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm of unknown size.It was reported that approximately 8 days post index procedure, the patient presented emergently and admitted to hospital with weakness, weight loss and feeling general unwell.The patient received dialysis, nutritional support with liquid and received a transfusion of one unit of red blood cells.Per the investigator, the cause of the event is not related to the device but possibly related to the procedure.No additional clinical sequelae were reported and the patient will be monitored.

Manufacturer Narrative

Additional information received; the patient was diagnosed with gastroenteritis.It was noted that the patient has an episode of rigors and pyrexia while admitted and was administered oral antibiotics.The sponsor assessed the event as possibly related to the procedure, the site concluded that it was neither related to device or procedure.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

Update; cancer (complete remission).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

It was reported there was procedural blood loss estimated at 1200ml.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

It was reported the intra-operative blood loss received medication as treatment and subsequently resolved.The site assessed this event as not related to the event and having a causal relationship to the procedure.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

It was confirmed that the blood loss was less than 500mls.No transfusion was given for that event.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The sponsor assessed this event as causally related to the procedure, but not related to the endurant or renal stents.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 7762627
• MDR Text Key: 116441391
• Report Number: 2953200-2018-01150
• Device Sequence Number: 0
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/04/2022
• 2 Devices were Involved in the Event: 1 2

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2018
• Initial Date FDA Received: 08/08/2018
• Supplement Dates Manufacturer Received: 08/13/2018; 08/08/2018; 08/08/2019; 08/25/2020; 09/17/2020; 09/14/2021; 12/07/2021
• Supplement Dates FDA Received: 09/06/2018; 10/02/2018; 09/03/2019; 09/21/2020; 10/12/2020; 10/13/2021; 01/04/2022
• Date Device Manufactured: 06/11/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male