MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number RLT311413

Device Problems Collapse (1099); Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Stenosis (2263)

Event Date 01/06/2020

Event Type  Injury  

Manufacturer Narrative

Additional devices included on this report are as follows: gore® dryseal flex sheath item #/lot # reportedly unavailable.This device is captured in manufacturer report #3007284313-2020-00021.The review of the manufacturing paperwork verified that the lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), indications for use and appropriate anatomy for use of the trunk-ipsilateral leg endoprosthesis includes a proximal aortic neck angulation of less than or equal to 60°.The safety and effectiveness of the gore® excluder® aaa endoprosthesis have not been evaluated in the following patient populations: patients with less than 15 mm in length or >60° angulation of the proximal aortic neck.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure-related adverse events that may occur and/or require intervention include, but are not limited to, endoleak.

Event Description

It was reported that, on the night of (b)(6) 2020, the patient presented with abdominal pain.It was determined that the patient had an abdominal aortic aneurysm.The patient underwent endovascular repair using gore® excluder® aaa endoprostheses.Reportedly the trunk of the trunk-ipsilateral leg component did not have full circumferential wall apposition proximally (a birdbeak was present) due to tortuosity of the patient's anatomy.The patient's aortic neck was reported to be about 90 degrees.It was also noted that, due to the anatomy and angle of the aorta, the device was difficult to deploy and did not land where intended.No additional action or correction was required for the device positioning.On (b)(6) 2020 the patient's pulse was unable to be located in the groin, and abdominal pain had returned.Leg pain was also present.It was determined that the proximal end of the trunk had collapsed and was infolded, reported as a crescent moon shape.A proximal type i endoleak was also present.The physician reportedly suspected that the type i endoleak, and graft collapse and infolding were due to tortuosity, angle of the patient's aortic neck, and the birdbeak that was present at the close of the initial procedure.No aneurysm enlargement was noted.On (b)(6) 2020 the patient underwent repair of the proximal type i endoleak.A gore® excluder® aaa aortic extender component was implanted, along with a cordis palmaz 4010 stent.Reportedly the endoleak was resolved.The procedure was completed.The patient tolerated the procedure.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• 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: jenna lopez ; 9285263030
• MDR Report Key: 9660854
• MDR Text Key: 188869158
• Report Number: 3007284313-2020-00022
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132619078
• UDI-Public: 00733132619078
• 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: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2022
• Device Model Number: RLT311413
• Device Catalogue Number: RLT311413
• Device Lot Number: 20693347
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2019
• 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: 75 YR
• Patient Weight: 92