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

Catalog Number PXA230300

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/16/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: patient medications include advair, strovite one, aspirin, tiotropium, levocarnitine, carvedilol, atorvastatin, amiodarone, renavite, and esomeprazole.A review of the manufacturing records for the device verified that the lot met all pre-release specifications.Per the gore® excluder® aaa endoprosthesis instructions for use (ifu), the physician and patient should review the risks and benefits when discussing this endovascular device and procedure, including the possibility that subsequent interventional or open surgical repair of the aneurysm may be required after initial endovascular repair.Per ifu, the aortic extender endoprosthesis is intended to be used after deployment of the gore® excluder® aaa endoprosthesis, and provides an extension of the leading (proximal) end of the trunk-ipsilateral leg endoprosthesis.

Event Description

On (b)(6) 2009, the patient was implanted with four gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.It was noted that an aortic extender component (pxa230300/06513365) was implanted distally on the left side.On an unknown date, computed tomography (ct) scan identified dilatation of the left common iliac artery.According to the report, the dilatation was caused by a progression of the existing aneurysmal disease.No endoleak or loss of vessel wall apposition was reported.On (b)(6) 2016, the patient underwent a re-intervention procedure whereby a gore® excluder® iliac branch endoprosthesis was implanted to treat the iliac artery aneurysm.The issue was resolved without any reported complications, 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 SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: damon jackson ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5889861
• MDR Text Key: 52560526
• Report Number: 2953161-2016-00166
• 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: 08/16/2016

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: 12/31/2011
• Device Catalogue Number: PXA230300
• Device Lot Number: 06513365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2009
• 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: 72 YR
• Patient Weight: 102