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

Model Number	PLC201400
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On june 4th, 2022, the patient was admitted for emergent treatment of a ruptured abdominal aortic aneurysm.As reported, the rupture occurred on the left side of the patient above the hypogastric.As reported, the patient was previously implanted with a non-gore device (medtronic) and had very torturous anatomy.Both limbs were relined successfully during the procedure.As reported, post-deployment, the catheter olive tip and the "railing" disconnected from the catheter and became dislodged in the common iliac.The entire catheter including the disconnected olive tip and railing was successfully removed from the patient.There was no serious injury to the patient.The catheter is being returned for evaluation.
Additional Manufacturer Narrative
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.The treating facility would not release information regarding patient comorbidities and medications.
Additional Manufacturer Narrative
H6.Code c20, no findings available the findings from the evaluation are consistent with the physician¿s observations that the olive tip and the railing disconnecting from the catheter.The cause for the catheter separation could not be determined with the currently available information.The catheter was returned for evaluation.The device evaluation showed the following: 1.The leading end of the catheter had separated from the catheter body at the trailing olive.2.The polyimide guidewire lumen had pulled out of the trailing olive bond on the catheter.3.The deployment knob and deployment line had been pulled out of the catheter.4.The device had been deployed off the catheter.5.There were gold material imprints from the polyimide guidewire lumen inside the trailing olive indicating that the olive had been bonded to the polyimide guidewire lumen.6.The end of the guidewire lumen was examined for fraying or other evidence of a tensile break.The end of the guidewire lumen had a clean cut at the end indicating the guidewire lumen did not break.7.The trailing end of leading olive was inspected for damage, and none was found.8.The trailing of the trailing leading olive was inspected for damage, and none was found.The findings from the evaluation are consistent with the physician¿s observations that the olive tip and the railing disconnecting from the catheter.The cause for the catheter separation could not be determined with the currently available information.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu): when withdrawing the device delivery system through the introduce sheath, verify all catheter components are intact.Warning: catheter leading end separation or breakage and related potential patient harms have occurred.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).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.D8/d9.Date device returned to manufacturer 22-jun-2022 g3/g4.Date received by manufacturer 12-aug-2022: : this reflects the date that all evaluations on the returned device were completed in full.H6.Code 3233, results pending completion of investigation was replaced with code c20, no findings available (see the additional information section for more specific details on this code).

• 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: breanna cox ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14776559
• Report Number: 3013164176-2022-01406
• Device Sequence Number: 5074179
• Product Code: MIH
• UDI-Device Identifier: 00733132618552
• UDI-Public: 00733132618552
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2022

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: 12/04/2024
• Device Model Number: PLC201400
• Device Catalogue Number: PLC201400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2022
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 91 KG