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

Catalog Number RLT311413

Device Problems Material Invagination (1336); Off-Label Use (1494); Patient-Device Incompatibility (2682)

Patient Problems Death (1802); Blood Loss (2597)

Event Date 01/08/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).Patient medications include aspirin, lipitor, cardura, hydrazine, hydrochlorothiazide, and lopressor.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 (ifu), the safety and effectiveness of the gore® excluder® aaa endoprosthesis have not been evaluated in patients with pending rupture or ruptured aneurysms, or patients with greater than 60 degrees angulation of the proximal aortic neck.Per ifu, adverse events that may occur and/or require intervention include, but are not limited to improper endoprosthesis component placement and death.

Event Description

On (b)(6) 2018, the patient presented emergently to the facility with a ruptured abdominal aortic aneurysm.The physician implanted two gore® excluder® aaa endoprostheses (rlt311413/17270729 and plc161000/17248503) to treat the rupture.According to the report, the patient¿s anatomy featured a 90-degree turn in the infrarenal aortic neck.The decision was made to land the proximal endoprosthesis below the angulated turn.Both devices were implanted without any reported issues, and the patient tolerated the procedure.On the following day, the patient expired.A computed tomography scan on this day reportedly showed that the proximal trunk had unintentionally been placed above the angulated turn in the infrarenal neck.The physician believes this positioning caused increased pressure against the proximal end of the endograft once blood flow was restored during the procedure.The increased pressure reportedly caused the proximal end to infold, which led to blood flowing around the graft and out of the ruptured aneurysm sac.

• 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: 7215701
• MDR Text Key: 98114384
• Report Number: 3007284313-2018-00033
• 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
• Report Date: 01/08/2018

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: 09/24/2020
• Device Catalogue Number: RLT311413
• Device Lot Number: 17270729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2017
• 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): Death
• Patient Age: 76 YR
• Patient Weight: 93