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

Catalog Number PLC271000

Device Problem Material Rupture (1546)

Patient Problems Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)

Event Date 03/27/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, the patient underwent treatment of an abdominal aortic aneurysm and bilateral common iliac artery aneurysms.Three gore excluder aaa endoprostheses were reportedly implanted with no issue.It was reported that during ballooning of the plc271000 in the patient¿s left common iliac artery (lcia) using a qxmedical q50-65 stent graft balloon catheter, the lcia ruptured, causing blood loss (amount unknown) and a drop in blood pressure.It was reported the rupture occurred as a result of ballooning in the patient¿s fragile, ectatic, and calcified iliac artery.Two occlusion balloons were advanced bilaterally to stop the blood loss, and a transfusion was administered to raise the blood pressure.A contralateral leg component was then implanted to repair the rupture, intentionally covering the left hypogastric artery.Final angiography showed exclusion of the aneurysms and rupture, and the patient tolerated the procedure.

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.

• 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: claire west ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 3752261
• MDR Text Key: 4481182
• Report Number: 3007284313-2014-00035
• 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: 03/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: PLC271000
• Device Lot Number: 12262951
• 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: 03/05/2014
• 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: 68 YR
• Patient Weight: 77