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

Model Number UNK-CV-SR-ENDURANT

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

Patient Problems Pulmonary Embolism (1498); Death (1802); Pain (1994); Pneumonia (2011); Swelling (2091); Thrombosis (2100); Injury (2348); Multiple Organ Failure (3261)

Event Date 07/13/2016

Event Type  Death  

Manufacturer Narrative

Medtronic received the following information obtained from the journal article entitled; thrombosis of the inferior vena cava after endovascular aortic repair in a patient with may-thurner syndrome: case report and literature review firouza dahi, asimakis gkremoutis, marc harth, thomas schmitz-rixen,and michael keese, frankfurt am main, germany http://dx.Doi.Org/10.1016/j.Avsg.2016.08.038 continuation from exact date of death is unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant stent graft system was implanted in the patient for the endovascular treatment of an infrarenal abdominal aortic aneurysm.It was reported that 7 weeks post the index procedure, the patient presented with acute, progressive swelling and pain in the left leg.Dvt of the ivc, and the common iliac, external iliac, femoral and popliteal veins of the left leg were diagnosed by ct scan and bilateral pulmonary emboli were also detected.A thrombectomy of the lower extremity and the ivc and the iliac vein was performed.For decompression of the ivc, parts of the aneurysm sac was resected.Furthermore, a balloon mounted, covered 8-mm stent (non mdt) was placed in the left common iliac vein after compression of the left iliac vein was diagnosed.An arteriovenous fistula between the left femoral artery and the great saphenous vein was created to enhance blood flow to the left pelvic vein.Four weeks later, the patient developed a postoperative pneumonia and died from septic multiple organ failure.Autopsy showed signs of septic multi-organ failure.No signs of graft infection were detected.No additional clinical sequelae were reported.

• Brand Name: ENDURANT
• 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: 7572578
• MDR Text Key: 110162908
• Report Number: 2953200-2018-00812
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 06/06/2018

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 Model Number: UNK-CV-SR-ENDURANT
• Device Catalogue Number: UNK-CV-SR-ENDURANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2018
• Initial Date FDA Received: 06/06/2018
• 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: 70 YR