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

Catalog Number PXC121000

Device Problems Premature Activation (1484); Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 02/10/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, the patient underwent treatment of an abdominal aortic aneurysm with gore excluder aaa endoprostheses.It was reported a contralateral leg component was being advanced through the right artery when the device deployed partially within the sheath.It was reported the sheath had not been pulled back completely prior to deployment, resulting in partial deployment within the sheath.The sheath was reportedly removed to completely deploy the device.However, it was reported angiography revealed that the device had landed distal to the contralateral gate and had unintentionally covered the right internal iliac artery.An additional device was implanted to bridge the trunk and contralateral leg component.Final angiography showed exclusion of the aneurysm, and the patient tolerated the procedure.

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.Patient medications include aspirin, crestor, folic acid, lasix, methotrexate, metoprolol, prednisone, zetia, coumadin and spiriva.

• 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 SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: charlene cooper ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 3658094
• MDR Text Key: 4283344
• Report Number: 2953161-2014-00024
• 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: 02/10/2014

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
• Device Expiration Date: 06/30/2015
• Device Catalogue Number: PXC121000
• Device Lot Number: 10555276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2012
• 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
• Patient Age: 66 YR
• Patient Weight: 103