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

Model Number UNK-CV-SR-ENDURANT

Device Problem Leak/Splash (1354)

Patient Problems Wound Dehiscence (1154); Renal Failure (2041); Thrombus (2101); Obstruction/Occlusion (2422)

Event Date 03/16/2019

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information obtained from the journal article entitled; explant of aortic stent grafts following endovascular aneurysm repair e boyle, sm mchugh, a elmallah , m lynch, d mcguire, z ahmed, c canning, mp colgan, sm o¿neill, a o¿callaghan, z martin and p madhavan department of vascular surgery, st.James¿s hospital, dublin 8, ireland doi: 10.1177/1708538119832727.Exact date of event unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant stent graft system was implanted in a patient for the endovascular treatment of a 55mm diameter abdominal aortic aneurysm.It was noted that the device was placed in the patient outside of ifu due to hostile neck anatomy.It was reported that patient had an explant procedure with an aorto-bi-iliac bypass due to a type ia endoleak and limb thrombosis, 54 months post index evar procedure.The patient had complication after the intervention procedure of sub-acute bowel obstruction, wound dehiscence requiring re-laparotomy and acute kidney injury.The cause of the endoleak and thrombosis is unknown but may have been related to challenging patient anatomy.No additional clinical sequelae were reported and the patient is fine.

• 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: 8548808
• MDR Text Key: 143030507
• Report Number: 2953200-2019-00558
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 04/25/2019

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 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: 04/01/2019
• Initial Date FDA Received: 04/25/2019
• 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): Required Intervention
• Patient Age: 73 YR