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

Catalog Number PLA360400J

Device Problems Material Separation (1562); Sticking (1597); Failure to Advance (2524); Device Operates Differently Than Expected (2913)

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

Event Date 06/04/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, the patient underwent endovascular repair of an abdominal aortic aneurysm with gore excluder aaa endoprosthesis using a c3 delivery system.After proximal deployment of a trunk ipsi-lateral leg component (rlt351416j/12352104), the physician could not rotate a clear knob to release the constraining system.After the physician confirmed that the constraining nut was returned to the default position, he tried again but could not rotate the clear knob to the left.He then decided to use a back-up mechanism, opening an access hatch on the c3 delivery system, releasing the rocked pin and the constraining system, and pulling off the second deployment line respectively.The deployment of the ipsi-lateral leg was done without any issue.The procedure continued and while the physician attempted to implant an aortic extender component (pla360300j/12582135), an introducer sheath could be inserted into an implanted device in the right iliac artery, but the pla itself could not be advanced further and got stuck.Once the physician was trying to pull the delivery catheter back into the sheath, the distal part of the pla on the delivery catheter was hooked on the proximal end of the sheath, and the leading olive separated from the catheter when the physician pulled the catheter forcefully.The pla was deployed in the right common iliac artery and the leading olive remained in the patient.The physician retrieved it from the patient using a snare catheter, and another pla was deployed in an appropriate position.The procedure was completed with no other issues reported.The patient tolerated the procedure.As per report, the physician pulled the delivery catheter back into the sheath without using a fluoroscopic image.Rlt351416j/12342104 will be returned to gore histology dept for evaluation, but pla360300j/12582135 was discarded at the facility.

Manufacturer Narrative

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

Manufacturer Narrative

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

• 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 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: yutaka uchiya ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 3899220
• MDR Text Key: 20713865
• Report Number: 3007284313-2014-00052
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/21/2014

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: 03/31/2017
• Device Catalogue Number: PLA360400J
• Device Lot Number: 12582135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2014
• 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
• Treatment: RLT351416J/12352104
• Patient Age: 86 YR