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

Catalog Number PLA260300J

Device Problem Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/19/2021

Event Type  malfunction  

Manufacturer Narrative

Additional devices included on this report are as follows: catalog #pla260300j/ serial #(b)(4)/ udi #(b)(4) which is captured in manufacturer report #3013164176-2021-01149.Patient weight: asked but unavailable.Concomitant medical products and therapy dates: asked but unavailable the device remains implanted, and the delivery catheters were discarded at the facility.An analysis of relevant data will be performed in view of supporting the identification of possible causes of the event.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure-related adverse events that may occur and/or require intervention or additional intraoperative procedure time include, but are not limited to, improper component placement.

Event Description

On (b)(6) 2021, the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.After all devices were implanted, angiography imaging reportedly revealed a slight proximal type i endoleak.It was reported that the physician attempted to implant an aortic extender component proximally to treat the proximal type i endoleak.Fluoroscopy imaging reportedly appeared to show that the aortic extender component was fully deployed.It was reported that the physician attempted to remove the device delivery catheter, but the device and the delivery catheter moved distally as one unit.It reportedly appeared that the deployment line of the aortic extender component was removed completely, but it was suggested by the field sales associate that the deployment line may have been broken.The aortic extender component was deployed within the trunk-ipsilateral leg component.The proximal type i endoleak remained, so an additional aortic extender component was implanted proximally.The proximal type i endoleak was resolved.The procedure was completed.The patient tolerated the procedure.

Manufacturer Narrative

H6: investigation conclusions: code 11 remains unchanged b5 event description corrected.

Event Description

Fluoroscopy imaging appeared to show that the aortic extender component was fully deployed.Afterwards, it was reported that the physician attempted to remove the device delivery catheter without confirming fluoroscopy imaging, but the device and the delivery catheter moved distally as one unit and the proximal end of the aortic extender component appeared deformed (three device marker bands were not located at the same height).It appeared that the deployment line of the aortic extender component was not pulled out completely.Then, during continued removal of the delivery catheter, the deployment line was completely pulled out or reportedly possibly the deployment line was broken.The aortic extender component was deployed within the trunk-ipsilateral leg component.Ballooning was performed to the device and the aortic extender component fully expanded (the three marker bands were located at the same height).The proximal type i endoleak remained, so an additional aortic extender component was implanted proximally above the patient's left renal artery.

Manufacturer Narrative

H6: investigation findings: code 213 - an analysis of relevant data was performed in view of supporting the identification of possible causes of the event.The engineering analysis stated the following: the device evaluation was performed based on what was reported to gore as the device was not returned for analysis.Without a physical sample to evaluate, the observation that ¿possibly the deployment line was broken¿ could not be confirmed.The physician¿s observation that the ¿device and the delivery catheter moved distally as one unit¿ when the catheter was removed and the observation that the ¿aortic extender component appeared deformed¿ could not be confirmed from the currently available information.The cause for the reported possibility that the deployment line was broken could not be determined with the currently available information.The cause of the device and the delivery catheter moving distally as one unit could not be determined with the currently available information.The report that the deployment line may not have been pulled out completely would explain the movement.The cause for the observation that the proximal end of the aortic extender component appeared deformed prior to ballooning could not be determined with the currently available information.The report that the deployment line may not have been pulled out completely would explain the deformation.The gore® excluder® aaa endoprosthesis instructions for use (ifu) states: o use fluoroscopic visualization for all guidewire, sheath and device catheter manipulations.O loosen the deployment knob.Using fluoroscopy, confirm final device position and deploy the aortic extender using a steady and continuous pull of the deployment knob to release the endoprosthesis.Pull the deployment knob straight out from the catheter side-arm.Deployment initiates from the trailing end of the device toward the leading end of the device.O warning: do not attempt to reposition the endoprosthesis after deployment has been initiated.Vessel damage or device misplacement may result.O use fluoroscopic guidance during the withdrawal of the delivery catheter to assure safe removal from, and to avoid catching on, the endoprosthesis.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure-related adverse events that may occur and/or require intervention or additional intraoperative procedure time include, but are not limited to, improper component placement and incomplete component deployment.Furthermore, the ifu states to use fluoroscopic visualization for all guidewire, sheath, and device catheter manipulations.Use fluoroscopic guidance during the withdrawal of the delivery catheter to assure safe removal from, and to avoid catching on, the endoprosthesis.Do not attempt to reposition the endoprosthesis after deployment has been initiated.Vessel damage or device misplacement may result.H6: investigation findings: code 3233 updated to code 213.H6:investigation conclusions: code 11 updated to code 4315.

• Brand Name: GORE EXCLUDERAAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11623080
• MDR Text Key: 244233489
• Report Number: 3013164176-2021-01150
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2023
• Device Catalogue Number: PLA260300J
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR