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

Device Problem Insufficient Information (3190)

Patient Problems Respiratory Distress (2045); Seroma (2069)

Event Date 07/01/2004

Event Type  Injury  

Manufacturer Narrative

This event is from the following literature article: demircin m, doðan r, özkan m, özsoy f, kuzgun e, güvener m.Perigraft seroma complicating the modified blalock-taussig shunts: two consecutive instances with review of literature.Turk j pediatr 2004; 46: 275-278.Date of event reflects date of publication which was july - september 2004.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, "perigraft seroma complicating the modified blalock-taussig shunts: two consecutive instances with review of literature" was reviewed.A single stage surgical repair was planned for a (b)(6) boy with tetralogy of fallot.A left modified b-t shunt was then performed with a 5 mm thin-walled gore-tex® vascular graft configured for pediatric shunts.Early postoperative period was uneventful, and the drainage tube was removed on the second postoperative day.The patient developed respiratory distress on the fifth day.Chest x-ray revealed left superior mediastinal mass.Thoracal computerized tomography (ct) demonstrated perigraft seroma.Re-thoracotomy was performed and the clear and gelatinous seroma material was removed and silicone drainage tube was replaced.The lung fully re-expanded soon after surgery and the patient was kept under controlled ventilation for one day.The composition of the drainage changed to chylous in nature on the third postoperative day and continued for seven more days (200 cc/day).Dietary control and continuous intravenous somatostatin infusion controlled the drainage.

• 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: 5567927
• MDR Text Key: 42411712
• Report Number: 2017233-2016-00345
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 03/16/2016

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: 04/11/2016
• 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
• Patient Age: 1 YR