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

Catalog Number PLA260300J

Device Problem Disconnection (1171)

Patient Problem Vascular Dissection (3160)

Event Date 08/05/2020

Event Type  Injury  

Manufacturer Narrative

According to the instructions for use (ifu) for the gore® excluder® aaa endoprosthesis; adverse events that may occur include, but are not limited to: endoprosthesis: migration a review of the manufacturing records for the device(s) is being conducted.

Event Description

On an unknown date, this patient underwent endovascular treatment for a chronic type b aortic dissection using other manufacturers stent graft.On (b)(6) 2016, the patient underwent re-intervention for treatment of a distal type i endoleak and was implanted with a gore® excluder® aortic extender component and a conformable gore® tag® thoracic endoprostheses (ctag).The patient tolerated the procedure without any issues.On (b)(6) 2020, the patient fell while riding a bicycle and suffered hemoptysis.Computed tomography performed this date determined a disconnect of the aortic extender and ctag device; and new ulcer like projection.The patient underwent emergent re-intervention and additional stent grafts were implanted to cover the disconnect.The patient tolerated the procedure.

Manufacturer Narrative

H6: updated code 213.

• Brand Name: GORE EXCLUDERAAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10398483
• MDR Text Key: 203102206
• Report Number: 2017233-2020-01120
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

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: No Information
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: PLA260300J
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 08/12/2020
• Supplement Dates Manufacturer Received: 08/05/2020
• Supplement Dates FDA Received: 02/26/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 82 YR