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

Model Number PLC271200

Device Problem Patient-Device Incompatibility (2682)

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

Event Date 12/09/2020

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications; according to the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to, endoleak.An evaluation was performed on returned images: there is no contrast visualized within the aneurism sac.There appears to be approximately 2.5cm of device apposition within the common iliac artery.There appears to be ~2.5cm from the r contra limb to the hypogastric origin.There is no contrast visualized outside the r contralateral limb.There is no contrast visualized outside the l contralateral limb.The l contralateral limb is within the iliac artery by ~3.3cm.

Event Description

On (b)(6) 2018, the patient was treated for an abdominal aortic aneurysm.The physician implanted a gore® excluder® aaa endoprosthesis featuring c3® delivery system and three gore® excluder® aaa endoprosthesis.On (b)(6) 2020, fsa (b)(6) reported that he was informed that the patient had a type ib endoleak, with an enlargement of an aneurysm of 1 cm.

• 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: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11109046
• MDR Text Key: 230002449
• Report Number: 3013164176-2021-01101
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618545
• UDI-Public: 00733132618545
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/04/2021

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: 02/25/2021
• 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: 12/10/2020
• Initial Date FDA Received: 01/04/2021
• Date Device Manufactured: 02/26/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 78 YR