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

Model Number RLT281218

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/10/2020

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.

Event Description

On (b)(6) 2020, (b)(6) was informed that a patient had a distal type i endoleak, and that a reintervention would take place on (b)(6) 2020.The physician states that the endoleak is likely due to disease progression received additional information from (b)(6).Reintervention took place on (b)(6) 2020.At that time, an excluder extender was implanted, which stopped the endoleak.Patient outcome was good.

Manufacturer Narrative

E1: added facility name.G1: revised manufacturing facility.

• Brand Name: GORE EXCLUDER AAA 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: 11117335
• MDR Text Key: 225105670
• Report Number: 3007284313-2021-01219
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132622511
• UDI-Public: 00733132622511
• 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: 05/11/2021

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: Health Professional
• Device Expiration Date: 09/25/2021
• Device Model Number: RLT281218
• Device Catalogue Number: RLT281218
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 01/05/2021
• Supplement Dates Manufacturer Received: 12/11/2020
• Supplement Dates FDA Received: 05/11/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR