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

Catalog Number PLC271000J

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/15/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The following was reported to gore: on (b)(6) 2017, the patient underwent endovascular procedure to treat an abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis.The procedure was completed with no issue.The patient tolerated the procedure.On an unknown date, follow-up imaging showed dilation of the right common iliac artery.The physician reported that the condition of the right common iliac artery was bad from the first.Therefore, re-intervention was performed on (b)(6) 2020.Gore® excluder® iliac branch endoprosthesis and a bridging contralateral leg component of gore® excluder® aaa endoprosthesis were additionally implanted from inside the previously implanted right leg to extend it.The procedure was completed 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, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 10809082
• MDR Text Key: 215320190
• Report Number: 2953161-2020-01027
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2020

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: 10/10/2019
• Device Catalogue Number: PLC271000J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 11/09/2020
• Date Device Manufactured: 10/10/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR