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

Device Problem Partial Blockage (1065)

Patient Problems Cardiac Arrest (1762); Death (1802); Ischemia (1942)

Event Date 05/27/2011

Event Type  Death  

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-gore-tex 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.After a median follow-up of 236 days (interquartile range, 116 to 340 days) and a cumulative observation of 48 patient-years, 7 late deaths were observed.It was stated that one patient had a prolonged cardiac arrest at home, was resuscitated, and transferred to the operating theatre because of evidence of a shunt blockage.The central shunt was taken down and replaced but subsequent magnetic resonance imaging scan of the brain demonstrated extensive cortical ischemia and treatment was withdrawn.

• 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: 5506349
• MDR Text Key: 40525710
• Report Number: 2017233-2016-00248
• 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
• Report Date: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2016
• 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): Death