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

Model Number PLC181000

Device Problem Unintended Movement (3026)

Patient Problem Aneurysm (1708)

Event Date 02/16/2021

Event Type  Injury  

Manufacturer Narrative

Additional devices implanted and/or related to this event: plc181000/(b)(4), udi (b)(4).Patient medications: lipitor, prilosec.The gore® excluder® aaa endoprosthesis instructions for use (ifu) states that adverse events that may occur and/or require intervention include, but are not limited to endoleak and component migration.

Event Description

On (b)(6) 2015, the patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.It was reported that the patient had a distal type i endoleak (date and modality of images is unknown) and one of the implanted contralateral leg endoprosthesis had migrated proximally into the aneurysm sac.There is no aneurysm sac enlargement.A contralateral leg endoprosthesis was implanted in each iliac artery during the original procedure.It is unknown which of implanted contralateral leg endoprosthesis device had migrated therefore both will be reported on.On (b)(6) 2021, the physician reintervened and extended the left limb device which had pulled up into the aneurysm sac.Landing the proximal end at the flow divider and the distal end in the left external iliac.The aneurysm was resolved, and the patient tolerated the procedure.

Manufacturer Narrative

Revised h6: investigation findings to code 213 ¿ no device problem found.A review of the manufacturing records indicated the lot met pre-release specifications.Revised h6: investigation conclusion to code 22 ¿ known inherent risk of device.The gore® excluder® aaa endoprosthesis instructions for use (ifu) states that adverse events that may occur and/or require intervention include, but are not limited to endoleak and component migration.

• 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: 11360572
• MDR Text Key: 232909350
• Report Number: 3013164176-2021-01123
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618743
• UDI-Public: 00733132618743
• 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: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2020
• Device Model Number: PLC181000
• Device Catalogue Number: PLC181000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 82