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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: review of the manufacturing records could not be performed as no lot number information was provided.No devices were returned to gore.Additional information about this event could not be obtained.As a result, no further investigation is possible.All information has been placed on file for use in tracking and trending.No actual event date was provided.Therefore, date of event is an estimate based on the date the article was accepted ((b)(6) 2017).(b)(4).

Event Description

Literature article "heparin-coated grafts reduce mortality in pediatric patients receiving systemic-to-pulmonary shunts" (adeel ashfaq, m.D.; mohammad soroya, m.D.; amit lyengar, m.D.; myke federman, m.D.; brian reemtsen, m.D.; ucla division of cardiac surgery, david geffen school of medicine at ucla, los angeles, ca, usa; published online: 13 january 2018) was reviewed.The article is a retrospective review of the institution's prospectively maintained society of thoracic surgeons (sts) database and electronic medical records.The timeframe of data collection was between may 2008 and december 2015.It was identified in table 2, 'unplanned reoperations' there were 9 patients identified as receiving non heparin coated stents.

• 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: craig bearchell ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7282395
• MDR Text Key: 100443859
• Report Number: 2017233-2018-00117
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• 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): Required Intervention