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

Model Number	PLC201000
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Abdominal Pain (1685); Aneurysm (1708); Ruptured Aneurysm (4436); Clinical Endoleak (4843)
Date of Event	04/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Code c20: a review of the manufacturing records for the device is going to be conducted.The investigation is in process.Further information will be provided.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 or Problem Description
On (b)(6) 2010, the patient had an abdominal aortic aneurysm repair using gore® excluder® aaa endoprostheses.Reportedly, on (b)(6) 2018, the left common iliac artery was also extended with one limb (plc201000/ 17526159).The graft on the left appeared to have pulled back a little bit from the common iliac bifurcation.We positioned and deployed a left external iliac limb to extend down to the common iliac bifurcation.(covered by the event# 40677.The medwatch report was sent to fda on june 1, 2019.) on (b)(6) 2021, the patient presented with an abdominal pain, hypotension and found to have a ruptured aaa secondary to the distal type i endoleak (have been already reported).The patient was subsequently taken to the or emergently on (b)(6) 2021 and underwent a procedure to place a gore® excluder® aaa contralateral leg endoprosthesis into the left iliac limb (20mm x11.5cm ) as well as endoprosthesis into the left common and external iliac artery (12mm x14 cm) for ruptured aaa and open ligation of circumflex iliac collateral with bilateral groin cutdown.On (b)(6) 2021, a follow up ct showed that the postoperative changes of aortic aneurysm repair with increased size of the aneurysmal sac, it was measured up to 96 mm transaxillary.Also, a persistent distal type endoleak was also present within the excluded aneurysmal sac.The patient tolerated the procedure.No pain.The cause of the aneurysm rupture is unknown.
Event or Problem Description
According to the site, they have to explant all gore® excluder® aaa endoprostheses.Dr.Settel reviewed the imaging- and he confirms every graft ever implanted was explanted.
Additional Manufacturer Narrative
B5: event description was updated due to the information received from the site.Code c19- a review of the manufacturing records for the device verified the lot met all pre-release specifications.The device was explanted and is not available for analysis.It was found that an aneurysm rupture was due to the aneurysm enlargement and to the distal type i endoleak.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention or additional intraoperative procedure time include, but are not limited to aneurysm enlargement, endoleak, aneurysm rupture and conversion.

• 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16641172
• Report Number: 3013164176-2023-01652
• Device Sequence Number: 5367650
• Product Code: MIH
• UDI-Device Identifier: 00733132618590
• UDI-Public: 00733132618590
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/05/2020
• Device Model Number: PLC201000
• Device Catalogue Number: PLC201000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2017
• 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: Required Intervention; Hospitalization; Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American