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

Catalog Number RLT261414

Device Problems Human-Device Interface Problem (2949); Insufficient Information (3190); Migration (4003)

Patient Problems Aneurysm (1708); No Information (3190)

Event Date 06/05/2018

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that these lots met all pre-release specifications.Rlt261414/17535681 udi#: (b)(4).(b)(4).According to the gore® excluder® aaa endoprostheses instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to component migration and surgical conversion.

Event Description

On (b)(6) 2018, the patient underwent endovascular procedure using a gore® excluder® aaa endoprosthesis featuring c3® delivery system to treat an abdominal aortic aneurysm.It was reported that when the physician advanced the device over a 16fr sheath (unknown), a lot of friction was felt.Reportedly, the device was deployed without any difficulties, however, was repositioned because the device was placed a little bit lower.The final deployment at the renal level was done without any problem.Nevertheless, it was impossible to release the delivery catheter from the introducer sheath, because the olive blocked off in the introducer sheath.Reportedly, the device was still well positioned during the control.The decision has been taken to remove the introducer sheath and the delivery catheter.While devices were out of the patient, the physician experienced some difficulties to remove the catheter over the guide wire.Pulling with more strength, the withdrawal was successful.A new introducer sheath was positioned and an angiography showed that the endoprosthesis (with both limbs contralateral and ipsilateral embedded) moved down significantly with the device squeezed in the aortic bifurcation and in the right common iliac artery.The decision to stop the procedure has been taken without clinic impact for the patient.According to the information provided, it was impossible to continue procedure due to the right hypogastric thrombosis.On (b)(6) 2018, the patient underwent an open surgery and a gore® excluder® aaa endoprosthesis featuring c3® delivery system was explanted.The procedure was completed with a dacron 18-9mm device.Additionally, a thrombectomy of the hypogastric artery was performed.

Manufacturer Narrative

The device was sent to gore for analysis.A detailed visual inspection of the delivery catheter revealed a kink on the blue outer-shaft located at approximately 32cm from the strain relief.Another kink was observed on the polyimide approximately 54cm from the strain relief.Engineering proceeded by inserting a guide-wire (amplatz extra stiff, 0.035¿) through the leading olive.The guide-wire was able to pass through the polyimide, however it was not possible to pass through the observed outer-shaft kink.The guide-wire was then inserted through the trailing end of the delivery catheter, through the tuohy-borst valve.Again, it was not possible to pass through the observed outer-shaft kink.The leading olive was visually inspected and did not reveal any damage.The explanted device was visually inspected and no abnormalities were observed.The introducer sheath was also inspected.A kink was observed at approximately 30cm from the over-molded hub.No occlusion, restriction or obstruction were noticed inside the sheath.A visual inspection of the leading end of the sheath did not reveal any damage.The gore® excluder® aaa endoprosthesis featuring c3® delivery system the warnings and precautions section of the indications for use (ifu) states: do not continue to withdraw the delivery catheter if resistance is felt during removal through the introducer sheath.Forcibly withdrawing the delivery catheter through the introducer sheath when resistance is encountered has resulted in adverse events including catheter separation and re-intervention.Incorrect deployment or migration of the endoprosthesis may require surgical intervention.Based on the findings from the evaluation, the physician¿s observation that it was impossible to release the delivery catheter from the introducer sheath, because the olive blocked off in the introducer sheath, could not be confirmed with the available information.It was not possible to confirm that when the physician advanced the device over a 16fr sheath, a lot of friction was felt.The physician¿s observation that the endoprosthesis moved down significantly with the device squeezed (compressed?) in the aortic bifurcation and in the right common iliac artery could not be confirmed, however this is consistent with the description that force was used to remove the catheter over the guide wire.Also, because the guide-wire was not returned, the physician¿s observation that while the introducer sheath and the delivery catheter were out of the patient it was not possible to remove the catheter over the guide wire could not be confirmed.It is not possible to determine if the observed kink on the outer-shaft, possibly due to the shipping back to the gore facility, contributed to the reported observation.The likely cause for the inability to release the catheter device from the introducer sheath could not be determined with the available information.This type of occurrence will continue to be monitored.According to the gore® excluder® aaa endoprostheses instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to component migration and surgical conversion.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7626217
• MDR Text Key: 111918674
• Report Number: 3007284313-2018-00185
• 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
• Report Date: 08/15/2018

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: 12/09/2020
• Device Catalogue Number: RLT261414
• Device Lot Number: 17535681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/21/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 91