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

Model Number ETLW1616C93E

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Anemia (1706); Bradycardia (1751); Flatus (1865); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Nausea (1970); Pain (1994); Vomiting (2144); Injury (2348); Abdominal Distention (2601)

Event Date 05/15/2018

Event Type  Injury  

Manufacturer Narrative

Continuation of medical devices: information references the main component of the system.Other relevant device(s) are: product id: etlw1610c124e, serial/lot #: (b)(4), ubd: 19-mar-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Heli-fx endoanchors and an endurant ii stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm.5 endoanchors were placed due to concern for late failure and due to an observed type ia endoleak.The type ia endoleak was resolved after the implantation of the endoanchors.It was reported that the day after the index procedure, the patient experienced acute lower back pain and abdominal pain with nausea and vomiting which was treated with medication.It was also reported the patients hb dropped most likely due to dilution to ivf.This was resolved with a blood transfusion.The patient was commenced on antibiotics for a suspected uti.A ct scan revealed no endoleak and a patent stent graft.Mild gaseous distention of the bowel representative of postoperative ileus was also seen on the ct.The patient was discharged the following day.Per the physician, the cause of the event is unknown.No additional clinical sequelae were reported, and the patient will be monitored.

Manufacturer Narrative

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.

• Brand Name: ENDURANT II ILIAC 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: 7741791
• MDR Text Key: 115764383
• Report Number: 2953200-2018-01123
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169467569
• UDI-Public: 00643169467569
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2018

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 Expiration Date: 01/02/2020
• Device Model Number: ETLW1616C93E
• Device Catalogue Number: ETLW1616C93E
• Device Lot Number: V07563069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 08/02/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 11/12/2018
• Supplement Dates FDA Received: 10/02/2018; 11/14/2018
• Date Device Manufactured: 01/02/2018
• 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: 73 YR