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

Model Number	PLA320400
Medical Device Problem Codes	Malposition of Device (2616); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.Communication with the source indicated there was no product malfunction.
Event or Problem Description
It was reported that on (b)(6) 2021, this patient had been scheduled to undergo a percutaneous replacement of the superior vena cava with the help of three gore® excluder® aortic extender components outside the instructions for use.During the procedure, a gore® excluder® aortic extender component pla320400 / 22903558 was deployed and had gone into the right ventricle of the heart.The pla component was subsequently retrieved from the ventricle and the patient without issues.Expecting to implant the second gore® excluder® aortic extender component right after the first one, the sterile pouch of a pla320400 / 22903558 had also been opened in the meantime but not used as the procedure was considered unsuccessful with the first pla not having been implanted.The patient tolerated the procedure.The pla320400 / 22903558 was reportedly discarded at the facility.The pla320400 / 22903558 was returned to tilburg warehouse for further processing.There is no further information available.
Event or Problem Description
It was reported that the pla320400 / 22903558 was returned to tilburg warehouse for further processing.
Additional Manufacturer Narrative
H6, component code: added code 515.B5, event description: updated part of event description.H6, medical device problem code: replaced code 4001 with code 2616.H6, investigation conclusions: replaced code 67 with code 4315.

• 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: thomas giebing ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12094412
• Report Number: 3013164176-2021-01208
• Device Sequence Number: 3926268
• Product Code: MIH
• UDI-Device Identifier: 00733132618804
• UDI-Public: 00733132618804
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2022

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: 12/15/2023
• Device Model Number: PLA320400
• Device Catalogue Number: PLA320400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2020
• 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: Hospitalization
• Patient Sex: Female