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

Catalog Number PXC121000J

Device Problem Insufficient Information (3190)

Patient Problems Aneurysm (1708); Seroma (2069)

Event Date 07/10/2017

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 (ifu), adverse events that may occur and / or require intervention include, but are not limited to aneurysm enlargement and surgical conversion.Device udi lot/serial: (b)(4), udi: (b)(4).Lot/serial: (b)(4), udi: (b)(4).Lot/serial: (b)(4), udi: (b)(4).

Event Description

On (b)(6) 2016, the patient underwent endovascular repair of an abdominal aortic aneurysm.A non-gore manufactured endoprosthesis (zenith device, cook medical) was deployed as a main body and gore® excluder® aaa endoprostheses contralateral leg and iliac extender components were implanted as device legs.The patient tolerated the procedure.A later follow-up study revealed aneurysm enlargement (amount of enlargement is unknown).On (b)(6) 2017, an open abdominal surgery was performed to treat the aneurysm enlargement.The existing endoprostheses were partially removed and replaced with a surgical graft.During the procedure, it was confirmed that seroma had been accumulated into the aneurysm sac (¿something that was accumulated in the aneurysm sac¿ was neither blood nor hematoma).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; flagstaff AZ
• Manufacturer (Section G): MEDICAL SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: yutaka uchiya ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6776321
• MDR Text Key: 82112829
• Report Number: 2953161-2017-00157
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/2017

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: 11/30/2018
• Device Catalogue Number: PXC121000J
• Device Lot Number: 14616463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2015
• 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
• Treatment: PXL161007J/14674348 AND PXL161207J/13257900
• Patient Outcome(s): Hospitalization; Required Intervention