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

Device Problems Occlusion Within Device (1423); No Flow (2991)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/01/2014

Event Type  Injury  

Event Description

In review of published literature, these findings were noted: min bao, ph.D., hongyin li, m.D., guangyu pan, m.D., zhonghua xu, m.D.And qingyu wu, m.D., "central shunt procedures for complex congenital heart diseases", j card surg 2014;xx:1-5 published online 2014, doi: 10.1111/jocs.12343.Between april 2004 and november 2012, total 110 patients (median age 11 months; median weight 9 kg) with the complex congenital heart diseases were treated with the gore-tex grafts in the shunt operation, the graft size was determined primarily based on the patients' body weight prior to the operations.The article describes acute graft occlusion occurred in one patient (4-mm shunt size), which was identified by a decrease in oxygen saturation and echocardiography showing no shunt flow at day 10 and day 30 after the shunt procedure.The patient underwent a second operation with a satisfactory outcome.

Manufacturer Narrative

No further information is available.

• 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 ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86001
• Manufacturer Contact: helen huang ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 3831603
• MDR Text Key: 4405504
• Report Number: 2017233-2014-00274
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K802095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2014

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/26/2014
• 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): Required Intervention