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

Catalog Number PXT231418

Device Problem No Apparent Adverse Event (3189)

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

Event Date 12/22/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4).It is unknown which of the three implanted devices were involved in the reported type ii endoleak.The devices information of the two additional devices are: pxc141200/06834335 (b)(4) and pxl161407/06693713 (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, aneurysm enlargement and surgical conversion.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.

Event Description

On (b)(6) 2010, this patient underwent an endovascular procedure to repair an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.Final angiography showed a type ii endoleak, and the physician elected to monitor the endoleak.The procedure was concluded, and the patient tolerated the procedure.On (b)(6) 2014, a reintervention was performed, and the lumber artery was coil embolized to repair the endoleak.The patient tolerated the procedure.However, computed tomography angiography (cta) seemed that the aneurysm was still enlarged (amount unknown) after the reintervention.The physician elected to monitor the patient.On (b)(6) 2018, it was confirmed that the aneurysm was rapidly enlarged (amount unknown).An open surgery was performed, and it was confirmed there was no endoleak.It was considered that the aneurysm enlarged due to vasa vasorum on the aneurysmal wall.The endoprostheses were explanted except the left leg in the left common iliac artery.The patient's aorta was replaced with a surgical graft and its left leg was anastomosed to the part of the endoprosthesis remained in the left common iliac artery.The open surgery was concluded with no issue.The patient tolerated the procedure.

• 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 SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: nataliya baramzina ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7306952
• MDR Text Key: 101297101
• Report Number: 2953161-2018-00022
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2013
• Device Catalogue Number: PXT231418
• Device Lot Number: 8308733
• 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: 09/01/2010
• 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: 77 YR