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

Catalog Number PXC141000

Device Problems Premature Activation (1484); Activation, Positioning or Separation Problem (2906)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 10/12/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device was discarded at the facility and, therefore, was unavailable for evaluation by gore.Per the gore® excluder® aaa endoprosthesis instructions for use (ifu), ilio-femoral access vessel size and morphology (minimal thrombus, calcium and / or tortuosity) should be compatible with vascular access techniques.

Event Description

On (b)(6) 2015, a gore® excluder® contralateral leg component (pxc141000/13994159) was to be implanted as part of an endovascular aortic repair.As the device was advanced through the introducer sheath, it was reportedly noted that the patient's left common iliac artery was moderately tortuous and calcified.According to the report, the physician had wanted to perform a wire exchange before moving forward with the procedure.It was reported that the physician attempted to withdraw the delivery catheter back through the sheath, but stopped when resistance was felt.It was suspected that the device may have partially deployed.The physician was able to remove the device and sheath together.Visual inspection of the delivery catheter reportedly confirmed that the device had prematurely and partially deployed.The cause of the unintentional deployment was unknown.The physician exchanged the wire and moved forward with the case using a new device.The procedure was concluded without any further reported complications.The patient tolerated the procedure.The delivery catheter was discarded at the facility.

• 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 ; 9285263030
• MDR Report Key: 5161500
• MDR Text Key: 29044016
• Report Number: 2953161-2015-00117
• 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: 10/12/2015

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: 05/31/2018
• Device Catalogue Number: PXC141000
• Device Lot Number: 13994159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2015
• 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: 73 YR