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

Catalog Number PXC141200

Device Problems Premature Activation (1484); Sticking (1597); Difficult to Advance (2920)

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

Event Date 12/22/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, the patient was implanted with a gore® excluder® aaa endoprosthesis featuring c3® delivery system to treat an abdominal aortic aneurysm.The ipsilateral device was successfully deployed on the right side following probing difficulties of the contralateral leg.Subsequently, a crossover approach inside the trunk was attempted.It was not possible to advance a catheter into the contralateral leg from the left as the former got stuck at the gate.The fsa reported that the physician attempted to push the sheath as close as possible towards the main trunk but the gore® dryseal sheath 1828 appeared to be too short in view of the patient¿s height.The physician nevertheless attempted to access the gate by employing alternate rotating movements with the catheter.It was then decided to retracted the device.During the retraction process, the device accidentally experienced full deployment, unintentionally covering the left internal iliac artery but leaving a gap between the trunk and the contralateral leg.The deployment coincided with the simultaneous separation of the wire which was subsequently snared by the physician.The gap between the contralateral leg and the trunk was bridged.The patient was doing well following the procedure.The fsa reported of the physician's reassurance that at no time, there was great force employed when performing manipulations.The physician has substantial working experience with the excluder endoprosthesis.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).The engineering evaluation has revealed the following: the guidewire and the introducer sheath used for the event were not returned, and are therefore unavailable for engineering evaluation.The returned delivery catheter for the product (pxc141200) exhibited polyimide guidewire lumen detachment at the leading end of the trailing olive junction.It appeared that the fracture was due to a polyimide guidewire lumen¿s tensile failure while the trailing olive junction remained intact.Based on the available information and evaluation of the returned portion of the product, the root cause for the polyimide detachment could not be determined at this time.This type of occurrence will continue to be trended and appropriate actions will be taken as they are deemed necessary.

• 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: thomas giebing ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4431579
• MDR Text Key: 5383756
• Report Number: 2953161-2015-00008
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/29/2015

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: 05/31/2017
• Device Catalogue Number: PXC141200
• Device Lot Number: 12763589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2015
• 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
• Treatment: RLT281416, LOT# 12983014PXC141000, LOT# 10909980
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 75 YR
• Patient Weight: 90