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

Model Number RLT231216

Device Problems Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2022

Event Type  malfunction  

Manufacturer Narrative

The following medical information was provided past medical history: hypercholesterolemia.Surgical history: removal of skin cancer, cataract(bilateral).Current medications: atorvastatin, acetaminophen.Allergies: no known allergies.(b)(4).Known inherent risk of device: catheter leading end separation or breakage and related potential patient harms have occurred.See adverse events.If catheter separation occurs, use best medical judgment to determine the appropriate course of action for the patient.Effective removal of the catheter component has been reported through both surgical (e.G.Cut down) and endovascular techniques (e.G.Snaring, sheath removal).According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require additional intraoperative procedure time or intervention include, but are not limited to: delivery system leading end catheter component retention.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

On (b)(6) 2022, the patient underwent treatment of an abdominal aortic to left iliac aneurysm and was implanted with gore® excluder® aaa endoprostheses and a gore® excluder® iliac branch endoprosthesis.As reported, post deployment of the gore® excluder® aaa endoprosthesis (rlt2312160) while taking the delivery catheter out, the nose cone on the leading end of the catheter sheared off partially and was still attached on the wire.As reported, the physician was able to back it off and pull it out with no impact to the patient.As reported, the positioning of the sheath when removing the catheter was not optimal.

Manufacturer Narrative

H6: added code e2403 under clinical code.H6: added code f26 under impact code.H6: added code a150207 under medical device problem code.H6: added code g04044 under component code.H6: added code b13 under type of investigation.H6: updated investigation findings to code c19.A review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.H6: conclusion coding updated.Catheter leading end separation or breakage and related potential patient harms have occurred.See adverse events.If catheter separation occurs, use best medical judgment to determine the appropriate course of action for the patient.Effective removal of the catheter component has been reported through both surgical (e.G.Cut down) and endovascular techniques (e.G.Snaring, sheath removal).According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require additional intraoperative procedure time or intervention include, but are not limited to: delivery system leading end catheter component retention.The imaging evaluation performed by a clinical imaging specialist showed the following: pre-implant cta is available for evaluation.There is a lci aneurysm present, external iliacs are tortuous bilaterally.The rci length measures ~ 22 mm in length, the lci length measures ~ 25 mm in length.Liia diameters measure < 6.5 mm at ~ 4 cm and 5 cm distal to liia ostium.Unable to confirm: leading end of catheter broken, leading olive separation.Engineering evaluation summary: additional information obtained by gore: it was confirmed that the leading olive came off the delivery system. the olive became caught on the tip of the sheath upon withdrawal of the delivery catheter. the item number was confirmed as dsf1633, but the lot number was unavailable.Vessel coverage was confirmed and the ibe limb was embolized to prevent a type ii endoleak.The imaging evaluation was unable to confirm the leading olive separation.No images were provided of the rlt delivery system, and it was not returned for engineering evaluation.Based on the findings from this evaluation, the physician¿s observation that the polyimide broke near the leading tip could not be confirmed.The likely cause for the polyimide break near the leading olive could not be determined with the available information.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: 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: breanna cox ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15904664
• MDR Text Key: 307924163
• Report Number: 3007284313-2022-02245
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132622344
• UDI-Public: 00733132622344
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

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
• Device Operator: Health Professional
• Device Model Number: RLT231216
• Device Catalogue Number: RLT231216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 12/02/2022
• Supplement Dates Manufacturer Received: 02/06/2023
• Supplement Dates FDA Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 79 KG