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

Catalog Number TGU343420J

Device Problem No Apparent Adverse Event (3189)

Patient Problem Aortic Dissection (2491)

Event Date 02/13/2018

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), complications associated with the use of the conformable gore® tag® thoracic endoprosthesis may include but are not limited to dissection of the aortic vessel and reoperation.(b)(4).

Event Description

On (b)(6) 2017, the patient underwent endovascular repair of a descending thoracic aortic aneurysm.Two conformable gore® tag® thoracic endoprostheses (proximal: tgu343420j/17263227, distal: tgu343415j/17374361) were successfully deployed.The patient tolerated the procedure.On (b)(6) 2018, a follow-up computed tomography (ct) was performed, revealing a retrograde thoracic aortic dissection originating from a new entry tear (stent-induced new entry, sine) which was located around the proximal end of the proximal endoprosthesis (tgu343420j).A reintervention was performed to repair the retrograde aortic dissection, whereby a conformable gore® tag® thoracic endoprosthesis was implanted proximal to the existing endoprosthesis (tgu343420j).As a chimney endoprosthesis, a gore® viabahn® endoprosthesis was deployed in the left subclavian artery.Then, a 24-fr gore® dryseal sheath with hydrophilic coating was advanced from the left common femoral artery and the endoprosthesis was successfully deployed.Intra-procedure imaging revealed a suspected cerebral infarct with the patient¿s consciousness level being deteriorated.It was reported by the physician that thrombus in the aortic arch could have spread, causing the suspected cerebral infarct.It was determined that the endovascular reintervention would be concluded first, followed by an intervention being performed to treat the suspected cerebral infarct.Another conformable gore® tag® thoracic endoprosthesis was implanted.The patient tolerated the procedure and a neurosurgeon underwent an intervention for the suspected cerebral infarct.A brain ct was performed but any apparent vessel obstruction was not confirmed.The neurosurgeon elected to monitor the suspected cerebral infarct.

• Brand Name: CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: yutaka uchiya ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7295472
• MDR Text Key: 100892235
• Report Number: 2017233-2018-00128
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040043
• 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: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2020
• Device Catalogue Number: TGU343420J
• Device Lot Number: 17263227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 80 YR