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

Catalog Number TAC083715A

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2024

Event Type  malfunction  

Manufacturer Narrative

H6: code c19 - the review of the manufacturing paperwork verified that this lot met all pre-release specifications.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 was treated for a zone 2 aortic dissection.The physician implanted a gore® tag® thoracic branch endoprosthesis.Midway through the deployment, the deployment string broke.It was reported that the physician was pulling the string at a 90° angle and created friction.It caused no patient harm.The last couple stitches were released via cardiac pressure from the patient and the case was completed without incident.

Manufacturer Narrative

Additional manufacturer narrative: according to the gore® tag® thoracic branch endoprosthesis instructions for use (ifu) the gore® tag® thoracic branch endoprosthesis is only compatible with the gore dryseal sheath family of devices.Compatibility with other sheaths has not been established.Use of any other introducer sheath may result in significant blood loss and/or damage to the endoprosthesis, delivery system, or catheter, which may cause premature or inadvertent deployment, or breakage.This ifu statement is now removed, as it does not accurately reflect the change in coding above.

Manufacturer Narrative

H10: additional manufacturer narrative: according to the gore® tag® thoracic branch endoprosthesis instructions for use (ifu) the gore® tag® thoracic branch endoprosthesis is only compatible with the gore dryseal sheath family of devices.Compatibility with other sheaths has not been established.Use of any other introducer sheath may result in significant blood loss and/or damage to the endoprosthesis, delivery system, or catheter, which may cause premature or inadvertent deployment, or breakage.

• Brand Name: GORE® TAG® THORACIC BRANCH 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: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18676673
• MDR Text Key: 336057283
• Report Number: 2017233-2024-04617
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P210032
• 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
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TAC083715A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 01/16/2024; 01/16/2024
• Supplement Dates FDA Received: 02/14/2024; 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2023
• 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
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 85 KG