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

Catalog Number TGU282815

Device Problem No Apparent Adverse Event (3189)

Patient Problem Death (1802)

Event Date 02/22/2019

Event Type  Death  

Manufacturer Narrative

A review of the manufacturing records could not be performed as device lot numbers were not available.The images and device were not available, the imaging evaluation and engineering evaluation could not be performed.(b)(4).

Event Description

The following publication was reviewed: " endovascular aortic repair is a viable strategy for treatment of primary infected abdominal aortic aneurysm¿ received through ann vasc surg 2020; 63: 117¿128.The authors: xiao di, changwei liu, rong zeng, and leng ni.The article aimed that infected abdominal aortic aneurysm (iaaa) is rare, and information is limited whether endovascular aortic repair (evar) can be considered a permanent treatment or is a temporary fix preceding open surgery.This retrospective study reviewed the short- and longterm outcomes of open surgery, emergent evar, and elective evar in the treatment of primary iaaa.The study population comprised 19 patients treated for iaaa at peking union medical college hospital between january 2008 and january 2017.Reported results stated there was one death (5.26%) among the 19 patients within the first postoperative 30 days.That patient (patient 4) had a sudden rupture of the abdominal aorta (implanted with gore excluder 28-150) during preoperative antimicrobial treatment and did not survive after the emergent evar procedure(post-op survival: 1 day).

Manufacturer Narrative

Patients diagnosed with a pre-existing rupture of the abdominal aorta artery, and whose death is attributed to the pre-existing rupture.Therefore, this event was determined to be non-reportable due to the pre-existing rupture mentioned in the article was not related to gore device.This medwatch will be voided.

• Brand Name: CONFORMABLE GORE TAGTHORACIC 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
• MDR Report Key: 10342805
• MDR Text Key: 200960659
• Report Number: 2017233-2020-01066
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TGU282815
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 47 YR