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

Model Number	RLT311415
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Gore is currently awaiting the return of the delivery catheter of the rlt311415 component to perform an evaluation of the device.
Event or Problem Description
On (b)(6) 2020, this patient underwent endovascular treatment for an uncomplicated abdominal aortic aneurysm, and was treated with gore® excluder® aaa endoprostheses.During the catheter retraction of a gore® excluder® trunk-ipsilateral leg component rlt311415 following deployment, it was noted that the leading end had become completely detached.Reportedly, it had slipped off the guidewire and had come to rest in the common iliac artery from where is was subsequently retrieved by the physician using endovascular means.There was no resistance felt, but a slight noise was heard when the catheter was removed.Also, no anatomical issues were reportedly identified to have contributed to the event.Gore is currently awaiting the return of the delivery catheter of the rlt311415 component to perform an evaluation of the device.
Additional Manufacturer Narrative
Health effect - impact code: added code.H6: code 213 - the review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.The gore® excluder® trunk-ipsilateral leg component rlt311415 / 21611979 was returned to gore and an engineering evaluation was performed.The device evaluation showed that the leading end is detached from the rest of the device.The polyimide length of the detached section is approximately 8cm from the base of the mid-olive and detached at the mid olive.The mid-olive is still attached to the delivery system and appears to be intact with no visible defects.The severed end of the polyimide was visually inspected.The polyimide appears to have been fractured.The other end of the fractured polyimide can be observed at the mid-olive transition.Based on the findings from this evaluation, the physician¿s observation that the leading end had become completely detached, was confirmed.The separation appears to be a fracture of the polyimide at the mid-olive transition of the catheter.Additionally, the physician¿s observation that no resistance was felt but a slight noise was heard when the catheter was removed cannot be confirmed.The likely cause for the fractured guidewire polyimide lumen could not be determined with the available information.
Additional Manufacturer Narrative
H6 - added codes for type of investigation and investigation findings.
Additional Manufacturer Narrative
H9: if action reported to fda under 21 usc 360i (f), list correction/removal reporting number: fsca#: 3007284313.12102019.001-c.A field safety corrective action was initiated (gore#: 3007284313.12102019.001-c) for similar potential failure modes.As part of the field safety corrective action, gore has sent a letter (jan 2020) to physicians and or hospitals with information about its investigation of leading end catheter separation events and has updated the ifu warnings related to leading end catheter separation events.The updated gore® excluder® aaa instructions for use (ifu) includes the following warning: do not continue advancing and withdrawing any portion of the delivery system if resistance is felt during advancement of the guidewire, sheath, or catheter.Stop and assess the cause of resistance.Vessel or catheter damage or premature deployment have occurred and may result in potential patient harms, see adverse events.
Additional Manufacturer Narrative
H6, component code: added code 788.
Additional Manufacturer Narrative
H6: investigation conclusions: code 22 "known inherent risk of device" is being retracted as it was determined that this code is not applicable to this medical device incident.

• 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: thomas giebing ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 10689985
• Report Number: 3007284313-2020-01112
• Device Sequence Number: 19810159
• Product Code: MIH
• UDI-Device Identifier: 00733132619085
• UDI-Public: 00733132619085
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/19/2021

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: 01/26/2023
• Device Model Number: RLT311415
• Device Catalogue Number: RLT311415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/18/2020
• Supplement Date Received by Manufacturer: 02/01/2021; 08/06/2021; 09/08/2021; 11/16/2021; 11/16/2021
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 03/02/2021; 09/03/2021; 09/17/2021; 11/17/2021; 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: SEE H10/11
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male