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

Catalog Number PXC141400

Device Problems Unintended Collision (1429); Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)

Patient Problem No Code Available (3191)

Event Date 05/15/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, the patient underwent treatment of a 9cm abdominal aortic aneurysm with a system of gore excluder aaa endoprostheses.It was reported the patient had a short (<15 mm) angulated proximal neck (exact measurements not given).As it was reported the patient¿s right kidney was atrophied prior to the procedure, the physician elected to intentionally cover the right renal artery and perform a snorkel procedure into the left renal artery.A brachial approach was utilized to implant a 6mm x 5cm gore viabahn endoprosthesis in to the left renal artery.It was reported full patency was established to the patient¿s left renal artery after completion of the snorkel procedure.Access was then obtained through the left femoral artery, whereby the trunk-ipsilateral leg component was deployed distal to the superior mesenteric artery.A contralateral leg component was implanted to provide distal extension into the left common iliac artery.Touch up ballooning was performed and it was reported all devices were implanted without issue.It was reported that the 12 fr gore dryseal sheath with hydrophilic coating being used was not long enough to reach the contralateral gate of the trunk, so the sheath was positioned distal to the gate.The contralateral leg component was advanced outside of the sheath to the level of the contralateral gate, but would not advance into the gate.It was reported the cause of the resistance during advancement of the device into the contralateral gate was due to the contralateral leg component interacting with the gate.It was reported the contralateral leg component caught on the contralateral gate during positioning.The endoprosthesis was rotated and advanced into the contralateral gate.The graft was advanced just proximal to the level of the flow divider within the trunk.An attempt was made to move the graft distal to the flow divider but this proved unsuccessful as a segment of the deployment line had come out of the delivery catheter causing the contralateral leg component to partially deploy and achieve wall apposition at the leading end of the graft.The contralateral leg component was then fully deployed.An additional guidewire and sheath were advanced through the brachial artery into the contralateral gate insuring additional access should it became necessary to position an additional contralateral limb parallel to the first contralateral leg component.This proved unnecessary as it was determined the contralateral leg component had successfully deployed within the contralateral gate.As the contralateral leg component delivery system was removed, it was noted the leading olive and polyimide remained inside the patient.An attempt was made to withdraw the leading olive and polyimide through a 7fr sheath but it this proved unsuccessful as the components continued to become caught on the tip of the sheath.Access was obtained through the brachial artery and the guidewire was snared.An attempted to withdraw the guidewire, leading olive and polyimide delivery components into the catheter again proved unsuccessful.The snare catheter was repositioned distal to the leading olive.All delivery components were successfully retrieved through the brachial access.The procedure concluded with an additional contralateral leg component deployed to extend distally into the right external iliac artery.Touch up ballooning was performed and final angiography showed resolution of the aneurysm, good proximal and distal seal and no evidence of an endoleak.The patient tolerated the procedure with no further issues noted.

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.The root cause of the leading olive and polyimide separation could not be determined with the provided information.

Manufacturer Narrative

Evaluation summary - the contralateral leg component was returned to gore for evaluation.During the investigation it was noted the polyimide guidewire lumen had detached at the leading end of the trailing olive junction.It appeared the detachment was due to a polyimide guidewire lumen¿s tensile failure while the trailing olive junction remained intact.Additionally, it was observed the free end of the deployment line did not appear to be clean-cut.The length of the returned segment of the deployment line from the free end of the deployment line to the male luer lock measured 53cm.As compared to the standard measurement of 119 cm.Based on the available information and evaluation of the returned portion of the product, the root cause for the reported deployment line break and the polyimide detachment could not be determined at this time.However, use outside of the ifu was noted and may have contributed to this event.

Manufacturer Narrative

• 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: charlene cooper ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 3822039
• MDR Text Key: 18730980
• Report Number: 2953161-2014-00062
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 08/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2014
• 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: PXC141400
• Device Lot Number: 12087592
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Treatment: NOT AVAILABLE.
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 91 YR
• Patient Weight: 66