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

Catalog Number PLC161000

Device Problems Premature Activation (1484); Material Separation (1562); Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/18/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015, the patient underwent an endovascular procedure in combination with an axillary-femoral bypass for treatment of an unknown etiology.An endovascular graft (manufacturer unknown) was reportedly advanced from the level of the left hypogastric artery up and over the aortic bifurcation to the origin of the right common iliac artery and successfully deployed.A gore® excluder® aaa endoprosthesis contralateral leg component was then selected for distal extension into the right external iliac artery.It was reported that as the contralateral leg component was being advanced through a cook® sheath, resistance was met and force was applied in an effort to advance the device through the sheath.At that point, angiography reportedly showed the leading olive had completely separated from the contralateral leg delivery catheter and remained within the cook® sheath, the deployment line had broken, and the device had prematurely deployed within the sheath.It was reported the excessive force applied during the attempt to advance the contralateral leg component through the cook® sheath may have caused or contributed to the leading olive separation and premature deployment.The leading olive and prematurely deployed endoprosthesis were successfully removed by removing the cook® sheath from the patient.The procedure was completed with a different device and cook® sheath, and 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 contralateral leg component delivery catheter was returned to gore for evaluation.During the investigation it was noted the polyimide guidewire lumen had detached at the leading end of the trailing olive junction.It appeared the detachment was due to a lack of bonding between the polyimide guidewire lumen and trailing olive.Based on the available information and evaluation of the returned portion of the product, the root cause for the polyimide detachment could not be determined at this time.However, use outside the ifu was noted, and may have contributed to this event.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), 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 of 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: charlene cooper ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4874663
• MDR Text Key: 5860403
• Report Number: 2953161-2015-00072
• 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,Followup
• Report Date: 07/29/2015

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: PLC161000
• Device Lot Number: 12979876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2015
• 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 Age: 56 YR