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

Model Number PLC271000

Device Problem Disconnection (1171)

Patient Problem Aneurysm (1708)

Event Date 10/21/2021

Event Type  Injury  

Event Description

The following information was reported to gore: on (b)(6) 2017 a patient underwent endovascular treatment of an iliac artery aneurysm which included the use of a gore® excluder® iliac branch endoprosthesis and a gore® excluder® aaa contralateral leg endoprosthesis as bridging limb.On an unknown date prior or equal to (b)(6) 2021 a type iii endoleak and aneurysm expansion of unknown amount due to dislocation of the right bridging limb from the gore® excluder® iliac branch endoprosthesis was discovered by imaging.The patient was not well enough to undergo any treatment.The case is ongoing.

Manufacturer Narrative

The gore® excluder® iliac branch endoprosthesis is being reported separately.A review of the manufacturing records for the device verified the lot met all pre-release specifications.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 and aneurysm enlargement.

Manufacturer Narrative

H6: component code added.

• 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: heidi inskeep ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12774405
• MDR Text Key: 280967393
• Report Number: 3013164176-2021-01264
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618538
• UDI-Public: 00733132618538
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2022

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: 05/03/2020
• Device Model Number: PLC271000
• Device Catalogue Number: PLC271000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2021
• Initial Date FDA Received: 11/08/2021
• Supplement Dates Manufacturer Received: 04/25/2022
• Supplement Dates FDA Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2017
• 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): Other
• Patient Sex: Male