MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE-TEX VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Obstruction/Occlusion (2422)

Event Date 01/04/2011

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

The following information was received through literature surgical management of pulmonary atresia with ventricular septal defect: early total correction versus shunt published by the society of thoracic surgeons, ann thorac surg 2011;91:1928 35.The study was to compare the surgical outcomes of shunt and early total correction.From 1997 to 2008, 47 patients with pulmonary atresia with ventricular septal defect and no major aortopulmonary collateral arteries who underwent surgical correction were enrolled in this retrospective study.Twenty-nine patients underwent palliative shunt operation (group s).The most commonly used shunt size was 3.5 mm in diameter (n=17) and this was followed by a 4-mm size shunt (n=8) with a gore-tex vascular graft (w.L.Gore assoc.Inc, (b)(4)).The results state that in terms of complications, in the shunt group, these interstage mortalities had the possibility of being associated with critical stenosis or occlusion of the shunt (4 patients).

Manufacturer Narrative

Literature citation: the literature name: ¿surgical management of pulmonary atresia with ventricular septal defect: early total correction versus shunt¿ published by the society of thoracic surgeons, ann thorac surg 2011;91:1928 ¿35.Accepted for publication jan 4, 2011.The authors: jae gun kwak, md, chang-ha lee, md, cheul lee, md, and chun soo park.Department of thoracic and cardiovascular surgery, sejong general hospital, bucheon, republic of korea doi:10.1016/j.Athoracsur.2011.01.014.

• Brand Name: GORE-TEX VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11918618
• MDR Text Key: 253675637
• Report Number: 2017233-2021-02047
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K802095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 07/19/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2021
• Initial Date FDA Received: 06/02/2021
• Supplement Dates Manufacturer Received: 05/19/2021
• Supplement Dates FDA Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 40 DA