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

Catalog Number RLT281418

Device Problem Sticking (1597)

Patient Problem Not Applicable (3189)

Event Date 02/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2018, this patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses featuring c3® delivery system.A trunk-ipsilateral leg component was advanced to the intended position and successfully deployed.When removing the c3® delivery catheter, it was reported that the delivery catheter got stuck on the aortic wire.Under fluoroscopy, the wire and delivery catheter were successfully removed together.The procedure was successfully concluded without further incident.The patient tolerated the procedure with good results.

• 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: laura crawford ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7364534
• MDR Text Key: 103539925
• Report Number: 3007284313-2018-00102
• 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: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2020
• Device Catalogue Number: RLT281418
• Device Lot Number: 16592796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2017
• 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 Age: 85 YR