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

Catalog Number RLT261414

Device Problem No Apparent Adverse Event (3189)

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

Event Date 11/24/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical devices: patient medications include toprol and zafera.Ct images dated (b)(6) 2017 were received by gore from the facility and an imaging evaluation was performed.A type ia endoleak was verified from the proximal edge of the excluder® device.The anatomical angle of the infrarenal neck was measured at 59 degrees, which falls within recommendations of the gore® excluder® aaa endoprosthesis instructions for use (ifu).There was approximately 2 cm of length from the lowest renal artery to the proximal end of the endoprosthesis.No other endoleaks were observed.The inferior mesenteric artery was noted as patent and filling retrograde, but not filling the aneurysm sac.A review of the manufacturing records for the device verified that the lot met all pre-release specifications.Per ifu, adverse events that may occur and/or require intervention include but are not limited to endoleak.

Event Description

On (b)(6) 2014, the patient was implanted with three gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.On (b)(6) 2017, computed tomography (ct) scan reportedly revealed a proximal type i endoleak contributing to aneurysm enlargement (amount unknown).A lack of proximal device apposition to the vessel wall was also reported.On (b)(6) 2018, the patient underwent a re-intervention procedure whereby two excluder® aortic extender components were implanted proximally to treat the type i endoleak.The endoleak was resolved and the patient tolerated the procedure.

Manufacturer Narrative

Original date of implant was (b)(6) 2014.

• 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: 7169477
• MDR Text Key: 96577419
• Report Number: 3007284313-2018-00006
• Device Sequence Number: 1
• Product Code: MIH
• 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,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: RLT261414
• Device Lot Number: 12611659
• 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: 05/08/2014
• 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: 68 YR
• Patient Weight: 80