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

Model Number RLT231412

Device Problems Partial Blockage (1065); Insufficient Information (3190); Patient Device Interaction Problem (4001); Migration (4003)

Patient Problems Hemorrhage/Bleeding (1888); Ruptured Aneurysm (4436)

Event Date 10/15/2023

Event Type  Injury  

Manufacturer Narrative

H.6.Code c21: a review of the manufacturing records for the device could not be conducted because the lot/serial number remains unknown.The device remains implanted and is not available for analysis.Further information was requested.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

It was reported that on (b)(6) 2023, a patient presenting with an aortoiliac ruptured aneurysm was treated with a gore® excluder® aaa endoprosthesis.The patient was in a bad condition.Reportedly, during the procedure, both iliac arteries were embolized.The patient became hemodynamically unstable two hours following the procedure.The patient was converted to open surgical repair.The physician observed that the trunk ipsilateral leg migrated out of the proximal neck.The physician did an open reconstruction.The patient subsequently died to unknown complications.

Manufacturer Narrative

H.6.Code c21: a review of the manufacturing records for the devices are going to be conducted.The investigation is in process.The devices remain implanted and are not available for analysis.Also were implanted: plc121000/(b)(6) udi# (b)(4).Plc121400/(b)(6) udi# (b)(4).Plc121200/(b)(6) udi# (b)(4).It is unknown what devices were implanted on the right and left side.All devices were reported at the same medwatch.Additional information was requested.

Event Description

On (b)(6) 2023, a patient was presented with an aortoiliac ruptured aneurysm and was treated with gore® excluder® aaa endoprostheses.The patient was in a bad condition due to the aneurysm rupture.It was reported that the patient had an angulated aortic neck and a large aortoiliac aneurysm.Reportedly, during the procedure, both iliac arteries were coil embolized.The patient became hemodynamically unstable two hours following the procedure.The patient was converted to open surgical repair.The physician observed that the trunk ipsilateral leg migrated distally out of the proximal neck for several cms.The physician did an open reconstruction.The patient subsequently died to open conversion and blood loss complications.It is unknown if the death was due to the ruptured aneurysm.Also, it is unknown if the device migration was due to the ruptured aneurysm.

Manufacturer Narrative

H1: type of reportable event was corrected.

Manufacturer Narrative

During the file review by clinical application specialist ¿ aortic (cas) and regulatory (ireg), it was determined that due to the main body (rlt231412/25690194) migration, the patient was converted to open surgical repair, and the patient subsequently died to open conversion and blood loss complications.The plc121000/25842753, plc121400/ 24175329 and plc121200/ 25871392 were not explanted due to the performance of the devices.There is no allegation against these devices, and they are not reportable as they do not meet the definition of a serious injury and a reportable malfunction.

Manufacturer Narrative

Type of reportable event corrected to 'serious injury.'.

Manufacturer Narrative

B5- event description was updated.B6: the data was updated.H.6.Code c19: a review of the manufacturing records for the devices verified that the lots met all pre-release specifications.The devices remain implanted and are not available for analysis.Please note that rlt231412/(b)(6) and plc121200/(b)(6) were implanted on the right side.Please note that plc121000/(b)(6) and plc121400/(b)(6) were implanted on the left side and reported separately- manufacturer report number 3013164176-2024-01951.The patient subsequently died due to open conversion and blood loss complications.It is unknown if the death was due to the ruptured aneurysm.Also, it is unknown if the device migration was due to the ruptured aneurysm.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 component migration, bleeding, conversion, and death.Per ifu, additional considerations for patient selection include but are not limited to: patient¿ s anatomical suitability for endovascular repair.The gore® excluder® aaa endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (aaa) disease and who have appropriate anatomy as proximal aortic neck angulation = 60°.Key anatomic elements that may affect successful exclusion of the aneurysm include severe proximal neck angulation.The ifu states: the safety and effectiveness of the gore® excluder® aaa endoprosthesis have not been evaluated in the following patient populations: leaking: pending rupture or ruptured aneurysms.

Event Description

On (b)(6) 2023, a patient was presented with an aortoiliac ruptured aneurysm and was treated with gore® excluder® aaa endoprostheses.The patient was in a bad condition due to the aneurysm rupture.It was reported that the patient had an angulated aortic neck and a large aortoiliac aneurysm.Reportedly, during the procedure, both left and right internal iliac arteries were coil embolized.The patient became hemodynamically unstable two hours following the procedure.The patient was converted to open surgical repair.The physician observed that the trunk ipsilateral leg migrated distally out of the proximal neck for several cms.The physician did an open reconstruction.On (b)(6) 2023, the patient subsequently died to open conversion and blood loss complications.It is unknown if the death was due to the ruptured aneurysm.Also, it is unknown if the device migration was due to the ruptured aneurysm.

• 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18378981
• MDR Text Key: 331174997
• Report Number: 3007284313-2023-02969
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132622368
• UDI-Public: 00733132622368
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup,Followup,Followup
• Report Date: 04/10/2024

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
• Device Operator: Health Professional
• Device Model Number: RLT231412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 12/22/2023; 01/04/2024; 01/04/2024; 02/29/2024; 04/10/2024
• Supplement Dates FDA Received: 01/03/2024; 01/10/2024; 01/25/2024; 03/04/2024; 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• 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): Required Intervention; Hospitalization; Death; Other
• Patient Age: 55 YR
• Patient Sex: Male