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

Model Number PLC271200

Device Problem Malposition of Device (2616)

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

Event Date 12/14/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient presented with an iliac artery aneurysm (iia) that had developed distally to a previously implanted endurant endoprosthesis on the patients right.It was intended to treat the iia with the implantation of gore® excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses (ibe).After the ibe devices were successfully implanted it was planned to use a contralateral leg endoprosthesis (plc) as a bridging device between the ibe and the previously implanted endurant endoprosthesis.It was reported that the plc was deployed more distally than intended due to intraprocedural imaging issues.The right internal iliac artery was unintentionally covered.The procedure was completed with successfully excluding the iia.No issues to the patient are known related to the coverage of the iia.

• 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: jörg kersten ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11156002
• MDR Text Key: 226316423
• Report Number: 3013164176-2021-01105
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618545
• UDI-Public: 00733132618545
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2021

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: 06/25/2023
• Device Model Number: PLC271200
• Device Catalogue Number: PLC271200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/25/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR