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

Catalog Number RMT231412

Device Problem Pressure Problem (3012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/26/2013

Event Type  Injury  

Event Description

On (b)(6) 2013, the patient was implanted with three gore excluder aaa endoprostheses to treat an abdominal aortic aneurysm.The max diameter of the aortic aneurysm was 40mm, the proximal aortic neck length is 3.2cm, and the max infrarenal aortic neck angle is 45 degrees.The diameter of the aortic bifurcation is 18mm.The physician reported the patient had a narrow distal aortic bifurcation.It was reported that on (b)(6) 2013, compression of both common iliac legs inside the aortic bifurcation occurred.On (b)(6) 2013, the physician reintervened and implanted iliac kissing stent with numbed cp stent 14x45 + 14x45.All devices are patent and the patient tolerated the procedure.

Manufacturer Narrative

The review of the manufacturing paperwork verified that these lots met all pre-release specifications.The gore excluder aaa endoprosthesis instructions for use (ifu) states: patients should be counseled as to the possibility of subsequent reinterventions including catheter-based and open surgical conversion.Additional devices implanted and/or related to this event: plc231200/11425497 and plc231200/11720210.

• 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 SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86001
• Manufacturer Contact: rachael chascsa ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 3738666
• MDR Text Key: 4277825
• Report Number: 2017233-2014-00186
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: RMT231412
• Device Lot Number: 11751971
• 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: 09/05/2013
• 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
• Treatment: PATIENT MEDICATION: ASPIRIN
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 70