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

Model Number	PLC201400
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	08/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, this patient underwent endovascular treatment of an intrarenal abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.The trunk-ipsilateral leg had been deployed to the contralateral gate, which was then cannulated, and a contralateral leg endoprosthesis was deployed.After the delivery catheter of the contralateral leg was withdrawn, the physician remarked on a visible density at the tip of the sheath, which remained in the patient.There had been no difficulty removing the delivery system.It was determined that the leading olive from the delivery catheter was on the guidewire and at the tip of the 12french dryseal sheath.The physician was able to manipulate the olive down the sheath but was concerned about pulling it completely out and potentially losing wire access.He decided to do a cutdown on the femoral artery to retrieve the olive.This was done successfully with no adverse effects to the patient.
Additional Manufacturer Narrative
H6: type of investigation, investigation findings and investigation conclusion codes h10/11: device evaluation summary - ¿ the device evaluation showed the following: o the deployment knob had been removed from the catheter.O the device had been deployed off the catheter.O the leading end of the catheter had separated from rest of the catheter.O the leading end of the catheter had pulled out of the trailing olive bond.O there was evidence the leading end of the catheter had been bonded at the trailing olive.¿ the findings from the evaluation are consistent with the physician¿s observations for leading catheter breakage.The report that the graft was still inside the sheath could not be confirmed because the introducer sheath was not returned for evaluation.¿ the gore® excluder® aaa endoprosthesis instructions for use (ifu) clearly states: o while maintaining the delivery catheter in position, withdraw the introducer sheath and visually verify that the leading end of the introducer sheath is below the distal contralateral leg radiopaque marker.O do not rotate the device delivery catheter while the endoprosthesis is inside the introducer sheath.Catheter breakage or premature deployment may occur.O do not continue advancing any portion of the delivery system if resistance is felt during advancement of the guidewire, sheath, or catheter.Stop and assess the cause of resistance.Vessel or catheter damage may occur.O do not attempt to withdraw any undeployed endoprosthesis through the introducer sheath.The sheath and catheter must be removed together.O 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 reintervention.¿ the cause for the catheter breakage could not be determined with the available information.
Additional Manufacturer Narrative
H6: type of investigation, investigation findings and investigation conclusion codes added g3/g4, h1/h2 added component code to h6 and conclusion code.H10/11: device evaluation summary - ¿ the device evaluation showed the following: o the deployment knob had been removed from the catheter.O the device had been deployed off the catheter.O the leading end of the catheter had separated from rest of the catheter.O the leading end of the catheter had pulled out of the trailing olive bond.O there was evidence the leading end of the catheter had been bonded at the trailing olive.¿ the findings from the evaluation are consistent with the physician¿s observations for leading catheter breakage.The report that the graft was still inside the sheath could not be confirmed because the introducer sheath was not returned for evaluation.¿ the gore® excluder® aaa endoprosthesis instructions for use (ifu) clearly states: o while maintaining the delivery catheter in position, withdraw the introducer sheath and visually verify that the leading end of the introducer sheath is below the distal contralateral leg radiopaque marker.O do not rotate the device delivery catheter while the endoprosthesis is inside the introducer sheath.Catheter breakage or premature deployment may occur.O do not continue advancing any portion of the delivery system if resistance is felt during advancement of the guidewire, sheath, or catheter.Stop and assess the cause of resistance.Vessel or catheter damage may occur.O do not attempt to withdraw any undeployed endoprosthesis through the introducer sheath.The sheath and catheter must be removed together.O 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 reintervention.¿ the cause for the catheter breakage could not be determined with the available information.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: douglas rhodes ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12440527
• Report Number: 3013164176-2021-01235
• Device Sequence Number: 14264258
• Product Code: MIH
• UDI-Device Identifier: 00733132618552
• UDI-Public: 00733132618552
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/07/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/23/2021
• Device Model Number: PLC201400
• Device Catalogue Number: PLC201400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 08/12/2021; 12/09/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 11/02/2021; 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Unknown