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

Catalog Number RLT231214

Device Problems Collapse (1099); Deformation Due to Compressive Stress (2889)

Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)

Event Date 08/31/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: the patient¿s medications include; acetaminophen, atenolol, calcium carbonate, lisinopril, lorazepam, methimazole, oxycodone and tramadol.According to the gore® excluder® aaa endoprosthesis featuring c3® delivery system instructions for use (ifu), the gore® excluder® aaa endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (aaa) disease and who have appropriate anatomy.Additional considerations for patient selection include but are not limited to the patient¿s anatomical suitability for endovascular repair.

Event Description

On (b)(6) 2017, the patient underwent endovascular treatment of an abdominal aortic aneurysm with gore® excluder® aaa endoprostheses featuring c3® delivery system.According to the report, all devices were positioned and implanted without issue.Final angiography showed complete exclusion of the aneurysm, and the patient was reported to have tolerated the procedure.On (b)(6) 2017, a follow-up computed tomography angiography (cta) scan identified evidence of ¿crimping¿ of the right sided ipsilateral limb of the trunk-ipsilateral leg component approximately 0.5 - 1 cm distal to the flow divider.Evidence of device occlusion was not reported.According to the report, the patient was asymptomatic, however due to physician¿s concern of future graft thrombosis an intervention will be performed.On (b)(6) 2017, an intervention was performed whereby an iliac extender component was positioned and implanted at the flow divider of the previously implanted trunk-ipsilateral leg component.Final angiography showed successful relining of the right ipsilateral limb and reportedly a patent device lumen.No further adverse events were reported 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: charlene cooper ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6973442
• MDR Text Key: 90089103
• Report Number: 3007284313-2017-00251
• 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: 09/29/2017

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: 02/23/2019
• Device Catalogue Number: RLT231214
• Device Lot Number: 14804970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2016
• 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: 63 YR
• Patient Weight: 67