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

Catalog Number TGU343420

Device Problem No Apparent Adverse Event (3189)

Patient Problems Death (1802); No Known Impact Or Consequence To Patient (2692)

Event Date 12/16/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).Lot/serial: 15150415 = (b)(4).The concomitant medical product was a gore® excluder® aaa endoprostheses (pxa320400/15213345).The therapy date was (b)(6) 2017.Udi information of the concomitant medical product as following.Lot/serial: 15213345 = (b)(4).

Event Description

It was reported to gore on december 17, 2017 that the patient had an descending aortic aneurysm and ulcer, as well as an abdominal artery aneurysm measuring above 5 cm.Considering the affordable medical treatment expense, during the procedure on (b)(6) 2017, the patient decided only accepting a treatment to the disease in descending aorta by implanting a gore® tag® thoracic endoprosthesis and a gore® excluder® aaa endoprosthesis as an extending graft.The abdominal artery aneurysm was not treated in this procedure.The procedure was completed successfully without any reported issue, the patient was stable post procedure and moved back to the regular hospital room.However, the patient claimed an abdominal pain in the mid night of (b)(6) 2017.In the early morning of (b)(6) 2017, the patient was restlessness and hard to calm down, then progressed a serious abdominal pain and a difficult breathing, the blood pressure could not be measured.A cardiopulmonary resuscitation was taken.Then the patient was moved to icu for continuous monitoring, treat and cure.In the afternoon, the patient progressed a cardiac arrest and the blood pressure could not be measured again.After being rescued for 30 mins by taking cardiac compression and medication treatment, the patient died from ineffectual rescue measures.The hospital had a discussion regarding the cause of death and following factors were mainly considered, 1) the abdominal artery aneurysm; 2) failure of cardio-pulmonary resuscitation.

• 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: helen huang ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7185144
• MDR Text Key: 97051866
• Report Number: 2017233-2018-00015
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2019
• Device Catalogue Number: TGU343420
• Device Lot Number: 15150415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Device Manufactured: 05/17/2016
• 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): Death
• Patient Age: 82 YR
• Patient Weight: 68