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

Device Problem Partial Blockage (1065)

Patient Problems High Blood Pressure/ Hypertension (1908); Thrombosis (2100)

Event Date 01/01/2008

Event Type  Injury  

Manufacturer Narrative

Event is from the following literature article: swain s, dharmapuram a, reddy p.Neonatal blalock-taussig shunt: technical aspects and postoperative management.Asian cardiovascular & thoracic annals 2008;16:7-10.No lot number information was supplied; therefore, no review of the manufacturing paperwork could be performed.The device remained implanted; consequently, a direct product analysis was not possible.

Event Description

In the medical literature, an article, "neonatal blalock-taussig shunt: technical aspects and postoperative management" was reviewed.Between april 2003 and march 2006, the surgical technique, postoperative management and results were studied for 19 neonates who underwent a modified blalock-taussig shunt procedure using the gore-tex® vascular graft configured for pediatric shunts.It was stated that the early results revealed two patients that had a suspected partial blockage of the graft.Heparin was given intravenously with a temporary increase in inotropics to maintain a higher blood pressure.Another patient developed acute thrombosis for which a shunt revision was performed postoperatively.

• 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: 5502652
• MDR Text Key: 40401271
• Report Number: 2017233-2016-00242
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• 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: 03/15/2016
• 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): Required Intervention