MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number RLT281414

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

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

Event Date 04/04/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).According to the gore® excluder® endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to aneurysm enlargement and endoleak.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) 2015 - the date of aneurysm enlargement.

Event Description

On (b)(6) 2015, this patient underwent endovascular treatment for an abdominal aortic aneurysm measuring 55.6 mm in diameter, and was implanted with gore® excluder® endoprostheses.The patient tolerated the procedure.On (b)(6) 2015, a follow-up cta showed that a maximum diameter of the aortic aneurysm/lesion was 57 mm.On (b)(6) 2015, a follow-up cta showed that a maximum diameter of the aortic aneurysm/lesion was 61 mm.From (b)(6) 2015 till (b)(6) 2016, the aneurysm size enlarged from 53 mm to 58.6 mm.It was reported that on (b)(6) 2017, a type ii endoleak was identified and the patient underwent a transaneurysmal sac embolization of a type ii endoleak.No further adverse events have been reported.

Manufacturer Narrative

The review of the manufacturing paperwork verified that these lots met all pre-release specifications.(b)(4).According to the gore® excluder® aaa endoprosthesis featuring c3® delivery system 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.

Event Description

It was reported that on (b)(6) 2017, a type ii endoleak was identified and the patient underwent a transaneurysmal sac embolization of a type ii endoleak.The completion angiography showed resolution of the endoleak.This information was covered by the event# (b)(4).From may 16, 2017 till july 25, 2017, the aneurysm size was measured 62mm.On (b)(6) 2019, a type ii endoleak was determined and the patient underwent transcollateral ima embolization.Reportedly, it was a continued aneurysm sac growth.It appears that both type ii endoleaks originated from the ima.The patient was discharged from the hospital on (b)(6) 2019.The completion angiography showed resolution of the endoleak.On (b)(6) 2019, the patient¿s follow up denied any symptoms of complications.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• 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: 7150094
• MDR Text Key: 95898056
• Report Number: 2017233-2017-00678
• 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,Followup
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2018
• Device Catalogue Number: RLT281414
• Device Lot Number: 13492230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2015
• 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: 77 YR
• Patient Weight: 124