MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE PROPATEN VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Catalog Number H050040J

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Seroma (2069)

Event Date 07/14/2021

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

The following was reported to gore: on unknown date in 2021, a gore® propaten® vascular graft and a thoratec vascular access graft were used in a hemodialysis shunt surgery.A design was; left brachial artery - propaten - thoratec - propaten - left basilic vein.The patient was hospitalized for a month in another hospital for cerebral hemorrhage.When the patient returned, a seroma was observed.The seroma was located 4cm from the anastomosis of the artery and was about the size of a ping-pong ball.On (b)(6) 2021, a part of propaten with seroma was replaced with a thoratec vascular access graft.The physician stated that the cerebral hemorrhage that led to the hospitalization and hypoalbuminemia was thought to be the cause of the seroma.The albumin level was 2.6 g/dl.There was no causal relationship between the cerebral hemorrhage and the propaten.

Manufacturer Narrative

A1 patient identifier - (b)(6).

Event Description

The following was reported to gore: on (b)(6) 2021, a gore® propaten® vascular graft and a thoratec vascular access graft were used in a hemodialysis shunt surgery.The devices were implanted in the left brachial artery with the propaten - thoratec - propaten and ending in the left basilic vein.The patient was hospitalized for a month in another hospital for cerebral hemorrhage.On (b)(6) 2021, a seroma was observed.The seroma was located 4cm from the anastomosis of the artery and was about the size of a ping-pong ball.On (b)(6) 2021, a part of the propaten device with seroma was replaced with a thoratec vascular access graft.

Manufacturer Narrative

B7: preexisting conditions.

• Brand Name: GORE PROPATEN VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 12271433
• MDR Text Key: 264976155
• Report Number: 2017233-2021-02218
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 10/01/2021

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 Catalogue Number: H050040J
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/03/2021
• Supplement Dates Manufacturer Received: 07/21/2021; 07/21/2021
• Supplement Dates FDA Received: 09/15/2021; 10/01/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention