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

Catalog Number PLC161400

Device Problems Premature Activation (1484); Detachment of Device or Device Component (2907); Difficult to Advance (2920)

Patient Problem No Code Available (3191)

Event Date 07/05/2015

Event Type  Injury  

Event Description

On an unknown date in 2013, the patient was implanted with an endologix® endovascular stent graft to treat a ruptured abdominal aortic aneurysm.On (b)(6) 2015, the patient was implanted with a gore® excluder® contralateral leg component ((b)(4)) in a re-intervention procedure to treat a type iii endoleak (perforated graft) on the left (contralateral) side.During the procedure, the physician reportedly had difficulty advancing the device to the desired position.According to the report, when an attempt was made to pull the device back through the sheath, the device partially and unintentionally deployed inside the sheath.The physician was ultimately able to implant the device in a satisfactory position.The endoleak was resolved, and the patient tolerated the procedure.On (b)(6) 2015, computed tomography scan and x-ray reportedly revealed what appeared to be a detached portion of the plc141600 delivery catheter, including the leading olive, seen in the descending thoracic aorta approximately 10 cm above the renal arteries.On (b)(6) 2015, the patient underwent an endovascular re-intervention procedure whereby the delivery catheter portion was snared and removed.The patient tolerated the procedure.The delivery catheter was discarded at the facility.

Manufacturer Narrative

Patient medications include aspirin, symbicort, atrovent, lopressor, percocet, and prednisone.A review of the manufacturing records for the device verified that the lot met all pre-release specifications.Per the gore® excluder® aaa endoprosthesis instructions for use (ifu), the safety and effectiveness of the gore excluder® aaa endoprosthesis have not been evaluated in the revision of previously placed stent grafts.The ifu states ¿do not continue advancing any portion of the delivery system if resistance is felt during advancement of the guidewire, sheath, or catheter.Stop and assess the cause of resistance.Vessel or catheter damage may occur¿.

• 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: damon jackson ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4910579
• MDR Text Key: 6028516
• Report Number: 2953161-2015-00075
• 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: 07/06/2015

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: 02/28/2018
• Device Catalogue Number: PLC161400
• Device Lot Number: 13645528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2015
• 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: 70 YR
• Patient Weight: 69