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

Catalog Number PLA260300

Device Problems Leak/Splash (1354); Material Rupture (1546)

Patient Problems Hemorrhage/Bleeding (1888); Thrombus (2101); Rupture (2208)

Event Date 08/25/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The review of the manufacturing paperwork verified that the lots met all pre-release specifications.

Event Description

On (b)(6) 2015, the patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.After the successful placement of the trunk-ipsilateral leg component, intra-procedure imaging showed a small proximal endoleak which was solved by implanting an aortic extender component pla260300.The final angiography run showed no issues and the patient tolerated the procedure.Follow-up imaging on (b)(6) 2015, identified an occult rupture of the aortic neck and it is unclear as to whether the ballooning might have played a role in the rupture event.A follow-up procedure employing a chimney implant is currently considered.It was reported that the implant procedure was within the instructions for use for the gore® excluder® aaa endoprosthesis (aortic neck angle below 60 degrees).The patient presented with a tapered neck from 25 to 21 cm.Reportedly, there was significant thrombus in the infrarenal area.

• 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: thomas giebing ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5226951
• MDR Text Key: 31345065
• Report Number: 2953161-2015-00133
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: PLA260300
• Device Lot Number: 13427851
• 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: 02/15/2015
• 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