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

Catalog Number RLT261412J

Device Problem No Apparent Adverse Event (3189)

Patient Problems Death (1802); Renal Failure (2041)

Event Date 01/30/2018

Event Type  Death  

Manufacturer Narrative

Concomitant medical products plc141400/16545692, plc201200/16336107, and pxl161407/15506387.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 renal failure and death.(b)(4).

Event Description

On (b)(6) 2018, the patient underwent endovascular repair of abdominal aortic and common iliac artery aneurysms using gore® excluder® aaa endoprostheses (rlt261412/17495820, plc141400/16545692, plc201200/16336107, and pxl161407/15506387).Prior to the initial procedure, chronic total occlusion (cto) had existed in the patient¿s right external iliac artery.Additionally, pre-existing calcification and stenosis were revealed in the patient¿s left leg, from the left external iliac to the left femoral arteries.Pre-dilation of the left external iliac artery was performed, and a 16-fr gore® dryseal flex introducer sheath was inserted into an intended position.Then, the cto lesion in the right external iliac artery was also dilated, and a 12-fr gore® dryseal flex introducer sheath was advanced.Trunk-ipsilateral leg and contralateral leg components were advanced and deployed from the left side, followed by contralateral and iliac extender components being implanted in the right side.Final angiography did not reveal endoleaks, and the patient tolerated the procedure.On (b)(6) 2018, the patient suffered from acute renal failure.Later on the same day, the patient got in cardiac arrest and expired.It was reported that the patient had not urinated post initial implant procedure, so the physician suspected an acute renal failure.Additionally, a possible cause of death was acute renal failure but an exact cause of death was unknown as an autopsy was not performed.

• 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: yutaka uchiya ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7295515
• MDR Text Key: 100884066
• Report Number: 3007284313-2018-00068
• 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: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2020
• Device Catalogue Number: RLT261412J
• Device Lot Number: 17495820
• 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: 11/29/2017
• 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: 82 YR