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

Model Number	RLT281418
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified the lot met all pre-release specifications.The device remains implanted.The delivery catheter was discarded and is not available for analysis.However, the video was provided for investigation.Further information will be provided.
Event or Problem Description
On (b)(6) 2021, the patient was implanted with a gore® excluder® aaa endoprosthesis featuring c3® delivery system to treat an abdominal aortic aneurysm.Reportedly, after the successful device deployment, the physician felt a resistance while withdrawing the catheter.After inspection and confirmation that there was nothing preventing the catheter to withdraw, it was concluded that the catheter was stuck in the guide wire.The physician removed the catheter in conjunction with the guide wire with no problem or consequence.The device was inspected on the table and it was confirmed that the catheter was stuck on the wire and it was impossible to remove the catheter off the wire.It was confirmed that the problem was not related with the patient¿s anatomy like calcium or tortuosity as insertion/deployment was without any problems.Reportedly, there was no harm to the patient.The patient tolerated the procedure.According to the information provided, it is unknown what caused the delivery catheter to become stuck on the wire during withdrawal.The catheter did not appear damaged.The delivery catheter was discarded and is not available for analysis.However, the video was provided for investigation.
Additional Manufacturer Narrative
Additional information: h6: codes: the code 4247 was used to explain that the engineering evaluation confirmed that the catheter was stuck on the wire.The device remains implanted and is not available for analysis.The delivery catheter was discarded and is not available for analysis.However, the video was provided for investigation.The device evaluation was performed based on a video (whatsapp video on (b)(6) 2021 at 3.15.03 pm (1).Mp4) attached to the case as the device was not returned for analysis.The evaluation of this video showed that the delivery catheter appeared to be stuck on the guidewire.The delivery catheter deflected during attempted guidewire retraction.Based on the findings from this evaluation, the physician¿s observation that ¿the catheter was stuck on the wire¿ was confirmed.Based on the deflection that was observed during attempted retraction of the guidewire, it is likely the point of resistance is located within the distal catheter shaft assembly.The likely cause for the device getting stuck on the guidewire 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
• MDR Report Key: 11676128
• Report Number: 3007284313-2021-01393
• Device Sequence Number: 3095724
• Product Code: MIH
• UDI-Device Identifier: 00733132622559
• UDI-Public: 00733132622559
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2021

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: 06/29/2022
• Device Model Number: RLT281418
• Device Catalogue Number: RLT281418
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE USED, LUNDERQUIST.
• Patient Age: 63 YR