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

Catalog Number PXA280300

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

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Rupture (2208)

Event Date 12/01/2013

Event Type  Injury  

Event Description

On (b)(6) 2013, the patient underwent treatment of a ruptured abdominal aortic aneurysm with three gore excluder aaa endoprostheses.It was reported the patient had a short proximal neck (amount unknown) due to the rupture.Approximately 4-5 months ago, an additional procedure was performed whereby coils were placed and onyx glue was injected to treat a proximal type i endoleak reportedly caused by the patient¿s short proximal neck.It was reported the endoleak did not resolve at the end of the procedure.On (b)(6) 2014, follow-up imaging again showed a proximal type i endoleak.It was reported there was no aneurysm growth, but the aneurysm measured 6.1 cm and the patient was complaining of persistent back pain.On (b)(6) 2014, an additional procedure was performed whereby an aortic extender component was implanted for proximal extension.It was reported the device was implanted with ~1.5 cm intentionally covering the right renal artery, and a 6 mm x 5 cm device was extended from the right renal artery above the additional pxa280300 to complete a snorkel procedure.The left renal artery had reportedly been covered by an aortic extender component during the initial treatment.Final angiography showed a small proximal type i endoleak.The procedure was completed with no further treatment, and the patient tolerated the procedure.It was reported that no additional follow up imaging is scheduled due to the patient experiencing kidney complications.No further adverse events were reported.

Manufacturer Narrative

The event date is being noted as (b)(6) 2013 to capture the approximate date on which the proximal type i endoleak was first treated.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.Additional device implanted and involved in this event: pxa280300/12034403.

• 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: claire west ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 3751481
• MDR Text Key: 21996726
• Report Number: 2953161-2014-00042
• 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: 04/01/2014

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: 08/31/2014
• Device Catalogue Number: PXA280300
• Device Lot Number: 9598430
• 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: 10/11/2011
• 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: DILTIAZEM, ALLOPURINOL, AND ACE INHIBITORS.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 50