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

Catalog Number RLT281412

Device Problems Difficult to Remove (1528); Physical Resistance (2578); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2017, a gore® excluder® aaa endoprosthesis featuring c3® delivery system was being prepared for advancement when resistance was reportedly noted when loading the device onto the guidewire.It was reported the device was not tracking well on the guidewire and was very difficult to advance.It was reported a decision was made to remove the device from the guidewire, but during retraction the device could not be removed.Force was reportedly applied to remove the device from the guidewire, after which point the catheter began to separate at the trailing olive / polyimide wire junction.It was reported that after the catheter started to separate, it was able to be removed from the guidewire.No obstructions were reportedly noted within the catheter itself.It was reported there were no kinks noted in the guidewire after removal of the delivery catheter.However, it was decided to use a new guidewire, and another device was able to be advanced and was successfully implanted.The procedure was completed with no adverse events to the patient.

Manufacturer Narrative

Udi: (b)(4).The device was discarded at the facility and was not available for evaluation.

• 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: claire west ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6843113
• MDR Text Key: 85115837
• Report Number: 3007284313-2017-00216
• 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: 10/06/2017

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: 07/16/2020
• Device Catalogue Number: RLT281412
• Device Lot Number: 16506940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2017
• 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: 65 YR
• Patient Weight: 117