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

Device Problem Insufficient Information (3190)

Patient Problems Aneurysm (1708); Death (1802); Hemorrhage/Bleeding (1888); Necrosis (1971); Tissue Damage (2104)

Event Date 02/28/2017

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device was not possible since the device size and lot number were unavailable.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), the safety and effectiveness of the gore® excluder® aaa endoprosthesis have not been evaluated in the following patient populations: leaking: pending rupture or ruptured aneurysms.Adverse events that may occur and/or require intervention include, but are not limited to surgical conversion, and death.

Event Description

On (b)(6) 2017, the patient was urgently admitted to the hospital and was treated with gore® excluder® aaa endoprostheses to treat a ruptured abdominal aortic aneurysm.The patient was becoming hemodynamically unstable upon arrival to the operating room.The abdomen was extremely tense and the patient had abdominal compartment syndrome.The endograft procedure was successful.It was reported there was a reintervention to explant the gore® excluder® aaa endoprostheses on (b)(6) 2017 due to continual bleeding after endograft repair.The endograft was extracted and the aneurysm was repaired with an aorto-aortic tube graft.The patient was very coagulopathic and received a very high amount of blood transfusion from the two operations.On (b)(6) 2017, the patient continued to bleed and was taken to the operating room for a third time.There was a washout of the abdomen performed and inspection of the intestines due to high lactic acidosis which could have been from ischemic or infarcted bowel.The colon and the left side and up and around the splenic flexure into the mid transverse colon was found to be grossly necrotic.A total colectomy was performed.On (b)(6) 2017 a fourth procedure was performed to inspect the abdomen, the patient had necrosis of the entirety of his small bowel.Compassionate withdrawal was discussed with the family.On (b)(6) 2017, the patient was extubated and soon after expired.The physician stated the cause of death is dead bowel.

Manufacturer Narrative

Additional information: review of the file determined this event to be non-reportable due to the patient already having a pre-existing condition that lead to their death and there is no allegation of deficiency on the gore device or procedure.This medwatch will be voided.

• 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 WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: rachael chascsa ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6432555
• MDR Text Key: 70815471
• Report Number: 2017233-2017-00149
• 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: 05/01/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: COUMADIN
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Weight: 108