MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® EXCLUDER® AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number RLT351414

Device Problem No Apparent Adverse Event (3189)

Patient Problems Aneurysm (1708); No Code Available (3191)

Event Date 01/04/2016

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.(b)(4).According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to endoleak and aneurysm enlargement.Users are made aware of the risks associated with type ii endoleaks in the ifu and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.The date of event will be used as (b)(6) 2016 - the date of aneurysm enlargement.

Event Description

On (b)(6) 2015, this patient underwent endovascular treatment for an abdominal aortic aneurysm rupture using gore® excluder® endoprostheses.Pre-treatment ct revealed that the maximum diameter of the aortic aneurysm/lesion was 71.2mm.The patient tolerated the procedure.No complications were reported and the patient was discharged on (b)(6) 2015.Reportedly, on (b)(6) 2016, the follow up computed tomography angiography (cta) revealed a type ii endoleak originated from the inferior mesenteric artery (ima) and lumbar arteries.From (b)(6) 2016 to (b)(6) 2017 the follow up cta showed that aneurysm enlarged from 73mm to 78mm.It was reported that on (b)(6) 2017, the patient underwent an ima and lumbar arteries ligation.According to the physician, the event was not related to device or procedure.No further adverse events have been reported.The patient was discharged on (b)(6) 2017.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WOODY MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: nataliya baramzina ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7284578
• MDR Text Key: 100510016
• Report Number: 2017233-2018-00121
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2018
• Device Catalogue Number: RLT351414
• Device Lot Number: 13882511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2015
• 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: 90 YR
• Patient Weight: 91