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

Catalog Number PLC231000

Device Problem Device Dislodged or Dislocated (2923)

Event Date 02/13/2024

Event Type  Injury  

Manufacturer Narrative

Code c19-a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.As the device was not accessible, the product history review (phr) review was the extend of the investigation.No device problem was found per review of these records.Code c20 - the device remains implanted and, therefore, was not available for direct analysis by gore.It should be noted that, per the gore® excluder® iliac branch endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to, endoleak.Patient images were provided.Imaging analysis was performed, and the following was reported: ¿ comparison axial series imaging (arterial contrast and delayed contrast) shows type ii endoleaks involving the ima and a lumbar artery.Increased contrast pooling's are seen on the delayed contrast series images.¿ contrast is seen in the rci.There is an ibe device implanted in the rci.Contrast is pooling near the ibe gate and the stent (possible vbx) extending into the right internal iliac artery.There is questionable stent wall apposition in the riia at the level of this gate and stent overlap.Contrast pooling's are not increased on the delayed series imaging thereby suggesting a type iii endoleak.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) 2020, patient underwent an endovascular procedure to treat an abdominal aortic aneurysm and a right iliac aneurysm utilizing gore® excluder® aaa endoprosthesis, gore® excluder® iliac branch endoprosthesis, and an unknown size gore® viabahn® vbx balloon expandable endoprosthesis (vbx stent graft) which was implanted in the internal iliac artery.On 2/13/2024, fsa called and notified physician reported patient has a possible unspecified leak with a possible reintervention.Further information to be provided.On 2/14/2024, it was reported there was a type ii endoeleak, suspected type 1 endoleak, and possible type 3 component disconnection.Plans for reintervention surgery will be scheduled for (b)(6) 2024.On 3/5/2024, it was reported patient underwent reintervention surgery on (b)(6) 2024 to treat these endoleaks.Fsa also reports an aortic extender was placed proximally, but the there was a leak in the ibe gate.Reportedly, during the procedure angiography was performed and a brisk type iii junctional leak was noted at the vbx stent graft.It appeared the vbx stent graft had recoiled (reduced in diameter) over time.Physician ballooned it with a 12 or 14 balloon, and the leak was resolved.The cause of this reduction in diameter is unknown.It was also reported the suspected type 1a was not confirmed at reintervention surgery.Only a type ii and type iii were observed.Patient tolerated the procedure.The cause of the endoleaks remains unknown.It is also unknown if there was aneurysm enlargement.No further patient information is available.

• 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: lillian espinoza ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18856456
• MDR Text Key: 337112324
• Report Number: 3013164176-2024-02006
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618576
• UDI-Public: 00733132618576
• 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
• Report Date: 03/07/2024

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 Expiration Date: 11/12/2022
• Device Catalogue Number: PLC231000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2019
• 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
• Patient Age: 85 YR
• Patient Sex: Male