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

Catalog Number PLA360400

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2015

Event Type  malfunction  

Event Description

On an unknown date, the patient was implanted with a medtronic captivia® stent graft system as part of a previous thoracic endovascular aortic repair.On (b)(6) 2015, an intervention was performed whereby an aortic extender component was to be implanted as part of a precautionary procedure for the prevention of an endoleak involving the previously implanted medtronic device.However, no evidence of endoleak was reported.Prior to deploying the aortic extender component the physician elected to balloon the medtronic device.The aortic extender was retracted into the sheath to facilitate the ballooning.Upon retracting the device into the sheath it was reported the graft prematurely deployed within the introducer sheath.The device was removed from the patient and the procedure concluded without further issue.The patient tolerated the procedure.

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.

Manufacturer Narrative

Evaluation summary - the introducer sheath and the delivery catheter were returned to gore for evaluation.During the investigation, it was observed that the delivery catheter was separated at the trailing olive, and the deployment knob remained screwed down.The returned product showed polyimide guidewire lumen detachment from the catheter¿s trailing olive junction.It appeared that the detachment was due to the trailing olive junction failure.It equally appeared that the retracted stent-graft and the detached polyimide guidewire lumen remained inside the introducer sheath.Based on the available information and evaluation of the returned product, no root cause could be determined.The root cause of the event could not be determined with the provided information.

Manufacturer Narrative

Implant date: if implanted, give date: device was not implanted.

• 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 86004 ; 9285263030
• MDR Report Key: 4729329
• MDR Text Key: 5668229
• Report Number: 2953161-2015-00041
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup,Followup
• Report Date: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: PLA360400
• Device Lot Number: 12956560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/22/2015; 05/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2014
• 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