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

Device Problem No Apparent Adverse Event (3189)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 08/23/2017

Event Type  Injury  

Manufacturer Narrative

As the exact date of the event is unknown, (b)(6) 2017, the date of conference presentation was estimated to be the date of event.(b)(4).As lot number(s) were unavailable a udi was not provided.The instructions for use (ifu) for the gore® excluder® aaa endoprosthesis states, adverse events that may occur and / or require intervention include but are not limited to: endoleak.

Event Description

The following information was presented on the conference ¿ ¿the 12th (b)(6) endovascular symposium¿ on (b)(6) 2017.Masayuki hara et al., ¿open aneurysm incision and aneurysmorrhaphy for aneurysm enlargement due to endoleak after evar¿.The presentation included six patients who underwent endovascular procedure to repair an abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis.After the initial procedure, aneurysm enlargement was confirmed in the six patients.The aneurysm was incised, and aneurysmorrhaphy was performed to repair the aneurysm enlargement.No further information was available.

• 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 MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: laura crawford ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6862081
• MDR Text Key: 85995510
• Report Number: 2017233-2017-00467
• 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,litera
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/23/2017

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: 09/13/2017
• 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
• Patient Outcome(s): Hospitalization; Other; Required Intervention