MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number TGU262615J

Device Problem Compatibility Problem (2960)

Patient Problem Death (1802)

Event Date 01/27/2019

Event Type  Death  

Manufacturer Narrative

According to the instructions for use (ifu) for the gore® tag® thoracic endoprosthesis; adverse events that may occur include, but are not limited to: access, delivery and deployment events, rupture, death.A review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.

Event Description

On (b)(6) 2019, this patient underwent emergent treatment for a perfusion abnormality associated with an acute stanford type b aortic dissection and was implanted with conformable gore® tag® thoracic endoprostheses.The patient's distal descending aorta was reported to be tortuous.During advancement of the first ctag device (intended to be implanted up in the aortic arch) it was reported that when the physician pushed the device up through the tortuous area of the distal descending aorta a rupture of this area occurred.The physician then chose to deploy the device as the distal component in the descending aorta and cover the rupture.A second ctag was then advanced and successfully implanted within the aortic arch in zone 2 as the proximal component.Post implant the patient's blood pressure decreased.The patient was transferred to the intensive care unit and subsequently died.The physician commented on the cause of the rupture of the descending aorta as follows: an attempt was made to straighten the tortuousity of the descending aorta using an egoist ultimate stiff guidewire, but was unsuccessful.The physician believes when pushing the first ctag device up through the tortuous area, the tensioned guidewire stressed the aorta and was likely the cause of the rupture.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8309966
• MDR Text Key: 135149758
• Report Number: 2017233-2019-00056
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/18/2019

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: 04/10/2021
• Device Catalogue Number: TGU262615J
• Device Lot Number: 18504990
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Other
• Patient Age: 79 YR