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

Catalog Number PLC231400

Device Problems Sticking (1597); Failure to Advance (2524)

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

Event Date 01/13/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, the patient was undergoing an intervention with gore® excluder® aaa endoprostheses to treat a right distal type i endoleak.After a 12 fr gore® dryseal sheath was advanced up the right side, a contralateral leg component reportedly became stuck about halfway into the sheath and would not advance further.An attempt was made to pull the delivery catheter out of the sheath, but it was reported the endoprosthesis felt like it was coming off of the delivery catheter.The device and sheath were removed together, and a new sheath was inserted to implant another device with no further issue.It was reported the difficulty advancing was caused by inserting the contralateral leg component into too small of a sheath.The patient tolerated the procedure.Evaluation summary - the contralateral leg component was returned to gore for evaluation.Visual inspection of the returned device confirmed the undeployed device was caught in the 12 fr introducer sheath.There was blood on the device, and the deployment knob had not been pulled.The introducer sheath was cut open to remove the device for further evaluation.There was no evidence of damage to the leading portion of the device or the leading olive.The trailing olive was separated from the outer shaft and slightly deformed at the trailing end.The trailing end of the endoprosthesis was pulled away from the polyimide and damaged.The evaluation of the returned device is consistent with the reported observations.The root cause(s) for the inability to insert the device through the introducer sheath was inserting a 23 mm contralateral leg component into a 12 fr sheath.The instructions for use recommends a 14 fr or larger introducer sheath for the 23 mm contralateral leg component.

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 WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86001
• Manufacturer Contact: claire west ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 3680029
• MDR Text Key: 20636482
• Report Number: 2017233-2014-00133
• 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: 03/11/2014

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: 01/31/2016
• Device Catalogue Number: PLC231400
• Device Lot Number: 11128135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2013
• 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: ASPIRIN, LISINOPRIL, AND PRAVASTATIN
• Patient Age: 65 YR
• Patient Weight: 125