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

Model Number	RLT311417
Medical Device Problem Code	Unintended Compatibility (4047)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The csa reported the following: on (b)(6) 2022, the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder aaa endoprostheses.It was reported that the gore® excluder® aaa trunk-ipsilateral leg endoprosthesis (rlt311417/23929725) was prepped on back table per the instructions for use.While attempting to advance the delivery catheter through the gore® dryseal flex introducer sheath valve, the valve ruptured.Two additional gore® dryseal flex introducer sheaths were used, and the valve¿s were ruptured.The csa instructed the doctor to not use this device at this point.Reportedly a metal piece (was determined by returned product photo's to be a lock pin) punctured the sheath valve.The lock pin was not visible, it was felt on the back table after the third dryseal flex sheath was punctured.The lock pin that was not visible was coming from the top of the graft, not the olive.A hemostat was used to stop blood loss (amount of blood loss is unknown).A blood transfusion was not required.The physician used a different device and a new sheath.The patient tolerated the procedure.
Event or Problem Description
The clinical specialist (cs) reported the following: on (b)(6) 2022, the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder aaa endoprostheses.It was reported that the gore® excluder® aaa trunk-ipsilateral leg endoprosthesis (rlt311417/23929725) was prepped on back table per the instructions for use.While attempting to advance the delivery catheter through the gore® dryseal flex introducer sheath valve, the valve ruptured.Two additional gore® dryseal flex introducer sheaths were used, and the valves were ruptured.The cs instructed the doctor to not use this device at this point.A dislodged lock pin punctured the sheath valve.The lock pin was not visible, it was felt on the back table after the third dryseal flex sheath was punctured.The lock pin was not visible and coming from the top of the graft, not the olive.A hemostat was used to stop blood loss (amount of blood loss is unknown).A blood transfusion was not required.The physician used a different device and a new sheath.The patient tolerated the procedure.
Additional Manufacturer Narrative
Addition section b.Correction h3, device was returned to gore for evaluation on may 18, 2022.Addition section h.

• 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14598578
• Report Number: 3007284313-2022-01951
• Device Sequence Number: 19356678
• Product Code: MIH
• UDI-Device Identifier: 00733132619092
• UDI-Public: 00733132619092
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/27/2024
• Device Model Number: RLT311417
• Device Catalogue Number: RLT311417
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 70 KG