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

Device Problem Device Alarm System (1012)

Patient Problems Stenosis (2263); Thrombosis/Thrombus (4440)

Event Date 05/01/2019

Event Type  Injury  

Event Description

The following publication was reviewed: "left ventricular assist device failure due to outflow graft compression by thrombofibrotic exudate." j thorac cardiovasc surg.2019 may ; 157(5): e259¿e261.Doi:10.1016/j.Jtcvs.2018.10.069.Author: gregory r.Jackson, md.A (b)(6) woman present to the hospital 26 months after lvad implantation with unrelenting low-flow alarms on her lvad controller.Cardiac computed tomography with angiography (ccta) demonstrated a near-vertical orientation of the lvad inflow cannula at the left ventricular apex with an unobstructed contrast column.There was severe stenosis at the distal aspect of the outflow graft near the anastomosis with the ascending aorta, most likely due to thrombus.The patient underwent re-do sternotomy with revision of the heartmate ii outflow graft.Intraoperative surgical findings revealed visible severe external compression of the graft originating between the graft and a surrounding gore-tex® vascular graft wrap used for reinforcement during initial device implantation.

Manufacturer Narrative

The gore tex vascular graft was not used as a vascular graft but used as a cover of the outflow graft of the left ventricular assist device (lvad).Blood flow went inside the outflow graft of the lvad from the pump body to the aorta, not inside the gore tex vascular graft.There is no suspected malfunction/deficiency of the gore tex vascular graft as it was not as used as intended and there is no identified harm to the patient by the gore tex vascular graft based on the information provided.As a result this medwatch will be retracted.

• Brand Name: GORE-TEX® 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
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: marcos ayala ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12408507
• MDR Text Key: 275856515
• Report Number: 2017233-2021-02322
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/16/2022

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: 08/05/2021
• Initial Date FDA Received: 09/01/2021
• Supplement Dates Manufacturer Received: 08/05/2021
• Supplement Dates FDA Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female