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

Catalog Number RLT231212

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2017

Event Type  malfunction  

Manufacturer Narrative

Lot # 15640917 (b)(4).Engineering evaluation - the gore® excluder® aaa endoprosthesis featuring c3® delivery system catheter and lunderquist® extra-stiff (.035) guidewire were returned to gore for evaluation.Blood was noted on the returned catheter and guidewire, however no abnormalities or damage was observed on the catheter.During the investigation of the catheter, the tuohy-borst valve was observed to be loose resulting in an inability to advance the guidewire through the tuohy-borst valve.Upon inspection, it was determined that the guidewire was fixed in the region of the leading olive.With additional manipulation, the guidewire was removed from the catheter.Upon removal of the guidewire, a plug of blood was observed on the guidewire.A clean 0.035¿ guidewire was then inserted into the tuohy-borst valve, and the catheter was able to move freely.Based on the findings from the evaluation, the reported observation regarding the catheter not moving on the lunderquist® extra-stiff (.035¿) guidewire was confirmed, however, the root cause for the catheter remaining ¿stuck¿ on the guidewire could not be determined with the available information.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.The root cause for the catheter remaining ¿stuck¿ on the guidewire could not be determined with the information provided.

Event Description

On (b)(6) 2017, the patient underwent endovascular repair of an abdominal aortic aneurysm with a gore® excluder® aaa endoprosthesis featuring c3® delivery system.The device was reportedly advanced on a lunderquist® extra-stiff (.035) guidewire into position and successfully deployed without any reported issues.It was reported that during withdrawal of the delivery catheter from the patient, the catheter would not move on the guidewire.Force was reportedly used in an effort to remove the delivery catheter however, the catheter remained ¿stuck¿ on the guidewire.The delivery catheter and guidewire were removed together from the patient.The procedure was completed with no further issue, and the patient tolerated the procedure.Reportedly, there were no anatomical restrictions that may have caused or contributed to the inability to remove the delivery system from the guidewire.

• 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 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: charlene cooper ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6516565
• MDR Text Key: 73735564
• Report Number: 3007284313-2017-00106
• 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: 04/04/2017

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: 10/31/2019
• Device Catalogue Number: RLT231212
• Device Lot Number: 15640917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2016
• 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: 66 YR