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

Catalog Number RLT261418

Device Problems Break (1069); Burst Container or Vessel (1074); Premature Activation (1484); Difficult to Remove (1528); Malposition of Device (2616); Activation Failure (3270)

Patient Problem No Information (3190)

Event Date 03/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device remains in the patient.The delivery catheter is going to be sent for analysis.Further information will be provided.

Event Description

On (b)(6) 2017 the patient underwent the endovascular procedure using a gore® excluder® aaa endoprosthesis featuring c3® delivery system.The contralateral leg of the trunk-ipsilateral leg component was deployed first, with the plan of deploying the ipsilateral leg after the proximal neck was open, as this would allow the ipsilateral leg to shorten approximately 1 cm.When the physician attempted to remove the constraining mechanism, the lock pin line appeared broken approximately 4 inches from the deployment handle.An attempt was made to open the deployment line access hatch, but the lock pin line appeared broken within the hatch, and the constraining loop line would not allow the proximal neck to remain fully expanded.The proximal neck was ballooned with a coda balloon, but the balloon burst during this attempt.As reported the balloon may have burst due to the protruding lock pin as the lock pin was identified on fluoroscopy.The trunk-ipsilateral leg component handle was dismantled, and the lock pin line could be visualized within the handle, but could not be accessed.A decision was then made to complete deployment of the trunk-ipsilateral leg component by deploying the ipsilateral leg.After steps were taken to deploy the device by removing the lock pin line and constraining loop line, it was noted the device had been deployed unintentionally covering the left internal iliac artery.A balloon was used to push the trunk-ipsilateral leg component proximally, resulting in the ipsilateral leg only partially covering the left internal iliac artery.The procedure was completed with good proximal seal and no other adverse events.The patient tolerated the procedure.

Manufacturer Narrative

(b)(4).The engineering evaluation is in process.Further information will be provided.

Manufacturer Narrative

The device was sent for analysis.The returned components consist of the 1st deployment knob and its deployment line, the constraining mechanism still attached by a section of the constraining loop to the manifold assembly, the handle covers, the back-up access hatch and what appears to be a section of the lock pin (4cm long).The lock pin and constraining loop are cut and detached from the constraining handle are also returned.The lock pin section that was cut when the delivery catheter was sectioned shows some damage at the cut end.The other two sections (one still attached to the constraining mechanism and the 4cm section) do not show such damage.The delivery catheter outer-shaft is severed at approximately one inch from the manifold assembly.The manifold assembly appears damaged, likely due to the physician attempts to reach the lock pin.Based on the findings from the evaluation, because the device was deployed, the physician¿s observation that pulling on the constraining loop through the back-up hatch was unsuccessful and kept closing the proximal neck could not be confirmed.The cause for the failure to deploy the stent graft completely during this event could not be determined with the currently available information.It is however likely that the lock pin broke inside the delivery catheter rendering the constraining mechanism inoperative.This is also likely the reason of the constraining loop closing the proximal neck, when unsuccessfully trying to remove the constraining mechanism.According to 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 component placement and occlusion of device or native vessel.The gore® excluder® aaa endoprosthesis instructions for use state that correct pre-treatment planning includes determining the accurate size of the patient¿s anatomy and the proper size of the endoprosthesis.According to the sizing guidelines for the rlt261418 the length of the endoprosthesis is 18cm.According to the ifu, read all instructions carefully.Failure to properly follow the instructions, warnings, and precautions may lead to serious surgical consequences or injury to the patient.

• 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: nataliya baramzina ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6446948
• MDR Text Key: 71293626
• Report Number: 3007284313-2017-00071
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2019
• Device Catalogue Number: RLT261418
• Device Lot Number: 15144314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2016
• 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; Other
• Patient Age: 75 YR