MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE-TEX® VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Device Problem Pressure Problem (3012)

Patient Problem Thrombosis (2100)

Event Date 05/27/2011

Event Type  Injury  

Manufacturer Narrative

Barozzi l, brizard c, galati j.Side-to-side aorto-gore-tex central shunt warrants central shunt patency and pulmonary arteries growth.Ann thorac surg 2011;92:1476¿82.No lot number information was supplied; therefore, no review of the manufacturing paperwork could be performed.The device was not returned; consequently, a direct product analysis was not possible.

Event Description

In the medical literature, an article, "side-to-side aorto-goretex central shunt warrants central shunt patency and pulmonary arteries growth" was reviewed.Between january 2000 and april 2010, 68 consecutive patients underwent side-to-side aorto-central shunts using the gore-tex® vascular graft configured for pediatric shunts.Median age at surgery was 31 days.Cardiac morphologies were tetralogy of fallot, pulmonary atresia with collateral dependant lung circulation, and other.Shunt sizes ranged from 3 to 6mm.The procedure was performed on cardiopulmonary bypass in 43 patients.It was stated that in one patient with pulmonary and tricuspid atresia, had already undergone two palliative shunting procedures in the past and underwent a bcps (bidirectional cavopulmonary shunt)procedure.The result of the bcps was unsatisfactory due to very high filling pressures; the bcps anastomosis was taken down and a central shunt performed.The first postoperative day an angiogram was performed because of persistent episodes of desaturation.An almost complete thrombosis of the shunt was diagnosed and the patient was reoperated.During reoperation, the proximal end of the shunt appeared flattened by the curvature of a very large aorta.The shunt was taken down.The left and right pulmonary arteries were disconnected and 2 separate shunts were performed on each side.The patient recovered successfully thereafter.

• Brand Name: GORE-TEX® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: sandra whicker ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5464260
• MDR Text Key: 39204061
• Report Number: 2017233-2016-00172
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K802095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening