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

Catalog Number HT084050J

Device Problem Fluid/Blood Leak (1250)

Patient Problems Wound Dehiscence (1154); Seroma (2069)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2015, an gore propaten vascular graft was used in a femoral - femoral artery bypass surgery to treat an occlusion of an iliac artery.The patient was discharged in good condition two weeks after the surgery.On an unknown date, the patient visited the hospital for a follow-up examination, and a leakage of the serous fluid from the graft was observed.The wound dehiscence was also observed due to the growing seroma.On an unknown date, a drainage was performed, and fibrin glue was applied on the graft to stop the fluid leakage.The wound dehiscence was also treated.On an unknown date at a follow-up examination, a resolution of the serous fluid leakage was confirmed.The physician will continue to monitor the patient.

• Brand Name: GORE PROPATEN® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): KENDRICK PEAK MPD B/P; 4250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: kanae rikimaru ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5986224
• MDR Text Key: 55883849
• Report Number: 2017233-2016-00764
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: HT084050J
• Device Lot Number: 4650220PP019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2014
• 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: 74 YR