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

Catalog Number PXT261418

Device Problem No Apparent Adverse Event (3189)

Patient Problem Aneurysm (1708)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

Date of event: as the exact date of event is unknown on this event, (b)(6) 2017 is determined as the date of event.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 endoleak and aneurysm enlargement.(b)(4).

Event Description

On (b)(6) 2012, the patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.A trunk-ipsilateral leg component (pxt261418/9251022) was deployed from the left side, followed by contralateral leg component implanted in the right side.Additionally, an iliac extender component was deployed for distal extension of the contralateral leg component.The patient tolerated the procedure.In (b)(6) 2017, a proximal type i endoleak was suspected.Aneurysm enlargement was also confirmed but the amount of enlargement is reportedly unknown.A reintervention was performed whereby a non-gore manufactured endoprosthesis was implanted proximal to the trunk-ipsilateral leg component.The endoleak was resolved and the patient tolerated the reintervention 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: 7445829
• MDR Text Key: 106005546
• Report Number: 2953161-2018-00035
• 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: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2014
• Device Catalogue Number: PXT261418
• Device Lot Number: 9251022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2011
• 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): Hospitalization; Required Intervention
• Patient Age: 82 YR