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

Model Number	PLC141400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was stated that after the gore® excluder® contralateral leg endoprosthesis was successfully deployed, the device catheter was retracted into the used gore® dryseal flex sheath.The physician stated that during the removal of the catheter out of the valve of the sheath he confused the proximal catheter part with the lunderquist guidewire and forcefully retracted it.In that situation the proximal olive detached from the catheter inside the sheath.It was stated that the olive remained on the guidewire and was removed together with the sheath out of the patient.The procedure was completed successfully and no harm to the patient was reported.
Event or Problem Description
It was stated that after the gore® excluder® contralateral leg endoprosthesis was successfully deployed, the device catheter was retracted into the used gore® dryseal flex sheath.The physician stated that during the removal of the catheter out of the valve of the sheath he confused the proximal catheter part with the lunderquist guidewire and forcefully retracted it.In that situation the proximal olive detached from the catheter inside the sheath but remianed on the guidewire.It was stated that the olive remained on the guidewire and was removed together with the sheath out of the patient.The procedure was completed successfully and no harm to the patient was reported.The device was not returned for evaluation.Without a physical sample to evaluate, the physician¿s observations could not be confirmed.
Additional Manufacturer Narrative
Updated b4 / updaed conclusion codes code 61: the gore® excluder® aaa endoprosthesis instructions for use (ifu), stest the following: - 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 breakage or separation resulting in potential patient harms.- when withdrawing the device delivery system through the introduce sheath, verify all catheter components are intact.

• 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: joerg kersten ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12877518
• Report Number: 3013164176-2021-01274
• Device Sequence Number: 19960746
• Product Code: MIH
• UDI-Device Identifier: 00733132618651
• UDI-Public: 00733132618651
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/03/2024
• Device Model Number: PLC141400
• Device Catalogue Number: PLC141400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 11/26/2021
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male