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

Catalog Number PXC141400

Device Problems Premature Activation (1484); Physical Resistance (2578)

Patient Problem Tissue Damage (2104)

Event Date 02/10/2016

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.(b)(4).

Event Description

On (b)(6) 2016, the patient underwent an endovascular repair of a pre-existing rupture of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.It was reported that the contralateral leg component was advanced outside of the sheath.It was reported while the device was advanced outside of the sheath the imaging device was "bumped into".The physician reportedly decided to withdraw the device back into a 11fr sheath to allow for another contrast run to confirm placement of the device.While the delivery catheter was being withdrawn into the sheath, the contralateral leg component reportedly met resistance and pre-deployed in the patient's common iliac.The cause of the pre deployment is reportedly unknown.A cut down procedure was reportedly performed and the contralateral leg component was removed.Another device was used to complete the procedure.The procedure concluded without any further complications, and the patient tolerated the procedure.

Manufacturer Narrative

Evaluation summary - the device was returned to gore for evaluation.During the investigation, it was observed the device was returned with the leading end of the delivery catheter broken at the trailing olive.The deployment knob was still screwed into the delivery catheter.The deployment line was broken outside of where it extended out of the trailing olive lumen.The device was no longer constrained.The broken end of the deployment line was still stitched through the corset sleeve.No damage was seen on the leading olive.

Event Description

On (b)(6) 2016, the patient underwent an endovascular repair of a pre-existing rupture of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.

• 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: marcos ayala ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5501990
• MDR Text Key: 40401406
• Report Number: 2953161-2016-00038
• 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,Followup
• Report Date: 05/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: PXC141400
• Device Lot Number: 14488033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/13/2016; 05/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2015
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR