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

Catalog Number CXT231412E

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Vascular Dissection (3160)

Event Date 03/27/2024

Event Type  Injury  

Manufacturer Narrative

H6: code c21- a review of the manufacturing record for the device is going to be conducted.The device remains implanted and is not available for investigation.Evaluation is in process.Further information will be provided.Additional information and images were requested but are not available.Code a27 was used to explain that the physician mentioned that the dissection was noticed 3.5cm above the renal arteries and believed that it was not device related.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) 2024, the patient underwent endovascular procedure to treat an abdominal aortic aneurysm using a gore® excluder® conformable aaa endoprosthesis.At some time during the implantation of the gore excluder conformable the patient developed a retrograde type b aortic dissection (tbad) from somewhere around the rental arteries up to the left subclavian artery.The physician mentioned that the dissection was noticed 3.5cm above the renal arteries and believed that it was not device related.Reportedly, a percutaneous access using 16fr sheath was taken to the level of the renal arteries.The device was advanced up to the level of the renal over a trumo guidewire advantage (tga), the conformable device was then moved into position.Despite being slightly lower than desired the device was not moved any further.The gate was then cannulated and verified with a gore® molding and occlusion balloon catheter (mob).The main body secondary sleeve was then deployed to help the main body sit naturally as it was perceived that it was not sitting as desired on the beta angle.The contralateral limb and the ipsilateral limb were deployed.The balloon was then used to at the proximal/distal and overlapping stents.On completion run it was identified there was an apparent type b aortic dissection.To potentially cover any entry tear distal to the renals and depressurize the false lumen, it was decided to cover the space between the renals and the proximal end of the conformable device.Angio runs and measurements were made, and an excluder conformable extension cuff was deemed to be too long as the main body shortened over the angulation.The angle was within the gore instruction for use- 78-degrees.A standard excluder cuff was successfully deployed to the level of the renals but was not ballooned as the physician felt the aortic extender was fully opened and they did not want to cause any further complications.Post operatively the patient is stable and otherwise healthy.It is unknown what caused a retrograde type b aortic dissection.It may be a manipulation during the procedure with a wire or mob37/27838614 or genetic, however, it was not confirmed by the physician.According to the physician, the dissection was not device related.Additional information and images were requested but are not available.

Manufacturer Narrative

B5: event description was updated.Code c19: a review of the manufacturing record for the device verified, the lot met all pre-release specifications.The device remains implanted.And is not available for investigation.A27 was used to explain, that the physician mentioned, that the dissection was noticed 3.5cm above the renal arteries.And believed, that it was not device related.Additional information and images were requested.However, are not available.According to the gore® excluder® conformable 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 dissection.

Event Description

On (b)(6) 2024, the patient underwent endovascular procedure.To treat an abdominal aortic aneurysm using a gore® excluder® conformable aaa endoprosthesis.At some time, during the implantation of the gore excluder conformable.The patient developed a retrograde type b aortic dissection (tbad).From somewhere around the rental arteries up to the left subclavian artery.The physician mentioned, that the dissection was noticed 3.5cm, above the renal arteries.And believed, that it was not device related.Reportedly, a percutaneous access using 16fr sheath was taken to the level of the renal arteries.The device was advanced up to the level of the renal over a trumo guidewire advantage (tga).The conformable device was then moved into position.Despite being slightly lower than desired, the device was not moved any further.The gate was then cannulated and verified, with a gore® molding and occlusion balloon catheter (mob).The main body secondary sleeve was then deployed to help the main body sit naturally, as it was perceived that it was not sitting as desired on the beta angle.The contralateral limb and the ipsilateral limb were deployed.The balloon was then used to at the proximal/distal and overlapping stents.On completion run, it was identified, there was an apparent type b aortic dissection.To potentially, cover any entry tear distal to the renals and depressurize, the false lumen.It was decided, to cover the space between the renals and the proximal end of the conformable device.Angio runs and measurements were made and an excluder conformable extension cuff was deemed to be too long, as the main body shortened over the angulation.The angle was within the gore instruction for use- 78-degrees.A standard excluder cuff was successfully deployed to the level of the renals, but was not ballooned.As the physician, felt the aortic extender was fully opened and they did not want to cause any further complications.Post operatively: the patient is stable and otherwise healthy.According to the fsa, it is unknown, what caused a retrograde type b aortic dissection.Per fsa, it may be a manipulation, during the procedure with a wire or mob37/(b)(4) or genetic.However, it was not confirmed, by the physician.According to the physician, the dissection was not device related.Additional information and images were requested, but are not available.

• Brand Name: GORE® EXCLUDER® CONFORMABLE 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: 19102303
• MDR Text Key: 340102208
• Report Number: 3007284313-2024-03171
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P200030
• 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: 04/29/2024

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 Catalogue Number: CXT231412E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2023
• 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; Other
• Patient Age: 61 YR
• Patient Sex: Female