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

Catalog Number PXC141000

Device Problems Break (1069); Premature Activation (1484); Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920)

Patient Problems Obstruction/Occlusion (2422); Device Embedded In Tissue or Plaque (3165)

Event Date 04/17/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2014, the patient was implanted with a gore excluder aaa endoprosthesis to treat an abdominal aortic aneurysm.During the procedure, the physician found it was difficult to advance a contralateral leg component (item: pxc141000/lot: 12081097) due to the vessel tortuosity.As the physician attempted to withdraw the device, it was reported the device automatically deployed in the right external iliac artery, unintentionally covering the right hypogastric artery.According to the report, the deployment knob on the delivery catheter had not yet been loosened.The catheter was reportedly found to be broken at the pebex junction, and the leading end of catheter remained inside the patient¿s body.The broken part of catheter was removed from the patient using a snare.An 18mm contralateral leg component (item: pxc181400/ lot: 10957158) was implanted under help of a distractor to connect the trunk-ipsilateral leg and the contralateral leg component auto-deployed in the right external iliac artery.On (b)(6) 2014, there reportedly has no symptom of adverse event from unintentional obstruction of the right internal iliac artery, the patient felt good.

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.Per the gore excluder aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to improper endoprosthesis component placement and occlusion of native vessel.Per the ifu, ilio-femoral access vessel size and morphology (minimal tortuosity) should be compatible with vascular access techniques and accessories of the delivery profile of the vascular introducer sheath.

• 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: helen huang ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 3817346
• MDR Text Key: 11898119
• Report Number: 2953161-2014-00059
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/24/2014

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: 11/30/2016
• Device Catalogue Number: PXC141000
• Device Lot Number: 12081097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/19/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/26/2014; 07/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 70