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

Device Problem Migration (4003)

Patient Problems Hemoptysis (1887); Pain (1994)

Event Date 03/12/2023

Event Type  Injury  

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.

Event Description

The following voluntary user facility mdr was received: mw5115737: conformable gore® tag®thoracic endoprosthesis implanted in 2017.Greater than 2cm proximal migration with enlargement of aneurysm.Prior type a and arch repair.Additional information has been requested.

Event Description

On an unknown date in 2017 the patient underwent treatment of an aortic aneurysm using a conformable gore® tag® thoracic endoprosthesis (ctag).It was noted that the patient had a prior type a aortic dissection and aortic arch repair.On an unknown date, the patient presented with severe back pain, hemoptysis, and approximately 20mm distal migration of the ctag device with endoleak (origin unavailable).Aneurysm enlargement was not reported.The root cause of the migration was reportedly unknown.It was reported that the ctag device was extended to the edge of the patient's left subclavian artery using a terumo relay®pro device.The hemoptysis resolved after treatment.The patient tolerated the reintervention.Additional information remains unavailable.

Manufacturer Narrative

B.3.Date of event: as the event date remains unavailable, but the "date of this report" on the voluntary user facility mdr was listed as 12-mar-2023, this date has been used as the estimated event date.B.5.Event description updated.D.4.Device information: the device lot/serial number was requested but was unavailable.Therefore, device information remains unknown.D.10.Concomitant medical products and therapy dates: asked but unavailable.H.4.Device manufacture date: as the device lot/serial number is unavailable, the device manufacture date is unknown.H.6.Health effect - clinical code: codes e0721 and e2330 added.H.6.Type of investigation: code b22 - attempts were made to obtain the device lot/serial number, and the lot/serial number was unavailable.No device history record review was able to be completed.H.6.Type of investigation: code b15 added.H.6.Type of investigation: code b15 - an image was provided, and an imaging evaluation was performed.H.6.Investigation findings for imaging evaluation: code c19 added.H.6.Investigation findings for imaging evaluation: code c19 - one jpeg image was submitted for evaluation.No name, date, or demographics were present on the image.Could not manipulate the image in any way (window leveling, taking diameter measurements, etc.).The uncovered apices appeared to be at or very near the left subclavian artery origin.The image had a pre-marked arrow on a contrast density.This density could be followed along the edge of the implanted device.There were no angiograms to support this finding or eliminate radiology artifacts.H.6.Investigation conclusions: code d12 added.According to the conformable gore® tag® thoracic endoprosthesis instructions for use, potential adverse events or complications associated with the use of the gore® tag® thoracic endoprosthesis include, but are not limited to, endoleak, endoprosthesis migration, and reoperation.H.6.Health effect - clinical code: code e050102 corrected to code e2121.H.6.Investigation findings for communication/interviews: code c21 updated to code c19.H.6.Investigation conclusions: code d16 updated to code d15.

• Brand Name: CONFORMABLE GORE® TAG®THORACIC 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 WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16792524
• MDR Text Key: 313801451
• Report Number: 2017233-2023-03879
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 04/22/2023
• Supplement Dates Manufacturer Received: 03/04/2024
• Supplement Dates FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 88 YR
• Patient Sex: Male