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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 01/25/2016

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: review of the manufacturing records could not be performed as no lot number information was provided.The device was not returned.Consequently, a direct product analysis was not possible.Because of the lack of information and the silence of the reporting party, we are unable to confirm this allegation.

Event Description

The complainant presented at the society of thoracic surgeons conference 'clinical experience with the bifurcated y-graft fontan procedure'.The presentation identified an early reoperation/reintervention related to the bifurcated gore-tex® stretch vascular graft: an inferior vena cava (ivc) anastomosis revision with thrombectomy.

Manufacturer Narrative

Additional manufacturer narrative: date of event: (b)(6) 2016.

• Brand Name: BIFURCATED GORE-TEX® STRETCH 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 86005
• Manufacturer Contact: craig bearchell ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5436516
• MDR Text Key: 38226461
• Report Number: 2017233-2016-00119
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K904282
• 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,Followup
• Report Date: 03/08/2016

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: 02/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/08/2016
• 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