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 Rupture (2208)

Event Date 09/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the manufacturing records for the device(s) could not be performed as item and lot numbers are unknown.Per the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to aneurysm enlargement and rupture.Per ifu, ¿in addition to the risks and benefits of endovascular repair, the physician should assess the patient¿s commitment and compliance to post-operative follow-up as necessary to ensure continuing safe and effective results.¿ additionally, the ifu states ¿all patients should be advised this treatment modality requires long-term, regular follow-up to assess patient¿s health status and stent-graft performance.¿.

Event Description

On an unknown date in 2011, the patient was implanted with a gore® excluder® aaa endoprosthesis (item and lot number unknown) to treat an abdominal aortic aneurysm.According to the report, the patient was subsequently lost to follow-up.On (b)(6) 2017, the patient presented emergently to the facility with abdominal pain.An examination revealed a ruptured left common iliac artery.According to the report, aortoiliac disease progression led to vessel dilation and rupture.The patient was implanted with two non-gore manufactured endografts to treat the rupture.The rupture was resolved and the patient tolerated the procedure.

• 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: damon jackson ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6870559
• MDR Text Key: 86419796
• Report Number: 2017233-2017-00474
• 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: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• 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
• 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; Required Intervention
• Patient Age: 91 YR