MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE PROPATEN VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 10MM AND GREATER DIAMETER

Model Number HT066080A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Seroma (2069)

Event Type  Injury  

Event Description

Gore propaten vascular graft implanted on (b)(6) 2019 at approx 1000.Upon arrival to pacu surgeon called to bring pt back for suspected hematoma.No hematoma found post op seroma related to porosity of av graft sweat.Device was explanted and a new graft was implanted.Fda safety report id# (b)(4).

• Brand Name: GORE PROPATEN VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 10MM AND GREATER DIAMETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC. ; flagstaff AZ 86003
• MDR Report Key: 9171996
• MDR Text Key: 161783880
• Report Number: MW5090273
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/07/2019

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
• Device Model Number: HT066080A
• Device Catalogue Number: HT066080A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Weight: 59