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

Catalog Number RLT231416J

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Code Available (3191)

Event Date 04/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the manufacturing records for the device verified that the lot met all pre-release specifications.Per the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to endoleak and aneurysm rupture.

Event Description

On (b)(6) 2016, the patient was implanted with a gore® excluder® aaa endoprosthesis to treat an abdominal aortic aneurysm.On an unknown date, follow-up imaging reportedly identified a type ib endoleak at the distal end of the ipsilateral leg (rlt231416j/14128172) on the right side.The endoleak reportedly contributed to a rupture of the aneurysm.On (b)(6) 2018, the patient underwent a re-intervention procedure to repair the endoleak and aneurysm rupture.The right internal iliac artery was embolized using a vascular plug, and an additional endoprosthesis was implanted to extend the stent graft system distally beyond the right internal iliac artery.A final procedural angiograph reportedly showed the endoleak was resolved, and the procedure was concluded.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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: damon jackson ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7434735
• MDR Text Key: 105634169
• Report Number: 3007284313-2018-00125
• 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: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2018
• Device Catalogue Number: RLT231416J
• Device Lot Number: 14128172
• 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: 07/30/2015
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR