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

Device Problems Leak/Splash (1354); Migration or Expulsion of Device (1395); Material Rupture (1546)

Patient Problems Hemorrhage/Bleeding (1888); Embolism/Embolus (4438)

Event Date 12/05/2022

Event Type  Injury  

Event Description

Excluder implant for aaa on (b)(6) 2022.Rupture on (b)(6) 2022.Acute perioperative rupture due to type i endoleak.Possible graft migration.Required proximal extension and bilateral renal fenestration.Subsequent coil embolization of type ii endoleak and exp laparotomy for graft infection.

• Brand Name: GORE EXCLUDER AAA ENDOGRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; flagstaff AZ
• MDR Report Key: 16545606
• MDR Text Key: 311389638
• Report Number: MW5115735
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Life Threatening
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White