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

Model Number	RLT281414
Medical Device Problem Codes	Break (1069); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to gore that a gore® excluder® aaa endoprosthesis (rlt281414) was intended to be used for an endovascular aneurysm repair (evar).The device was introduced in the aorta and placed under the renal arteries.Upon initial the deployment, resistance was experienced when pulling the handle.The deployment line was not visible and the physician believed that the deployment line broke inside the catheter very shortly after the handle.The physician tried to unfold the prosthesis via the backup deployment mechanism, however, it was not possible to pull the first deployment line further.The device was removed through the sheath still undeployed and a gore® excluder® conformable aaa endoprosthesis (cxt281412e) was implanted successfully.
Additional Manufacturer Narrative
No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.The following investigation is ongoing: product history review, engineering evaluation of the returned device.
Additional Manufacturer Narrative
A review of the manufacturing records indicated the lot met all pre-release specifications.The gore® excluder® aaa endoprosthesis has been returned to manufacturer.Engineering evaluation of the device showed the following: -visual examination showed that the backup hatch was removed, and the first deployment line was pulled but not completely.-engineering attempted to pull the first deployment line from the back up hatch and was unable to do so.The endoprosthesis and catheter bent as the line was pulled.-engineering took a closer look at the sleeve under magnification and the first two stitches of the sleeve were unlaced.The first deployment line appeared to be laced incorrectly at the third stitch, resulting in the line becoming stuck and unable to be deployed or unlaced.The physician¿s observation that the deployment line broke and the device was unable to be deployed from the backup deployment mechanism, was confirmed.The likely cause that the first deployment line broke and the device was unable to be deployed is the deployment line was laced incorrectly in the sleeve.Capa request was submitted to initiate review of this event.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include but are not limited to incomplete component deployment.Corrected h6: added health effect - impact code 4642.Added medical device problem code 3270.Added component code 788.Updated investigation findings code to 706 - assembly problem identified.Code 3233 is no longer applicable.Updated investigation conclusions codes to 23, 4315, and 22.Code 11 is no longer applicable.Code 706 refer to the type of investigation code 10 (testing of the returned device).Conclusions code 23: the likely cause that the first deployment line broke and the device was unable to be deployed is the deployment line was laced incorrectly in the sleeve.Conclusions code 4315: a review of the manufacturing records indicated the lot met all pre-release specifications.

• 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: ida simson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14278143
• Report Number: 3007284313-2022-01885
• Device Sequence Number: 12090319
• Product Code: MIH
• UDI-Device Identifier: 00733132622535
• UDI-Public: 00733132622535
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2022

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: 07/26/2024
• Device Model Number: RLT281414
• Device Catalogue Number: RLT281414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/22/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GORE® DRYSEAL FLEX INTRODUCER SHEATH 18F
• Outcome Attributed to Adverse Event: Other
• Patient Age: 86 YR
• Patient Sex: Male