MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE TEX VASCULAR GRAFT (LINED); PROSTHESIS, VASCULAR GRAFT

Device Problem Complete Blockage (1094)

Patient Problem Thrombus (2101)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

Review of the manufacturing records could not be completed as no lot number information was provided.The device was not returned.Consequently, a direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no further investigation is possible.Reference medwatch #2017233-2020-00245, #2017233-2020-00246, and #2017233-2020-00247 for additional individual patient events within the article.

Event Description

The following article was reviewed: 'left ventricular assist device outflow graft obstruction - a complication specific to polytetrafluoroethylene covering.A word of caution!' talal alnabelsi, m.D.; alexis shafii, m.D.; john gurley, m.D.; kenneth dulnuan, m.D.; dwight harris, m.D.; maya guglin, m.D.; american society for artificial internal organs (asaio) journal: august 2019-volume 65 - issue 6 - p e58-e62; doi: 10.1097/mat.0000000000000929.The article discusses the evolution of left ventricular assist devices (lvads) and how they have changed the management of end-stage heart failure and the practice of heart transplantation.The article reports that polytetrafluoroethylene (ptfe) grafts have customarily been used to cover the outflow graft by surgeons to reduce adhesions and facilitate reentry sternotomy at the time of heart transplantation or left ventricular assist device (lvad) exchange.The article reports the presentation, diagnosis, and treatment of four cases of outflow graft obstruction because of formation of thrombus between the outflow graft and its protective ptfe cover.The patient presented with end-stage ischemic cardiomyopathy who underwent placement of a heartware hvad.A 20mm ptfe shield graft was placed around the outflow graft during lvad placement.The patient presented 41 months after implantation with dizziness and blurred vision.Computed tomography angiography (cta) of the chest showed an eccentric thrombus at the distal portion of the outflow cannula.A heartware pump exchange procedure was undertaken.During the procedure the outflow graft was resected in its entirety.Direct examination intraoperatively revealed extensive clot formation in the space between the ptfe covering and outflow graft causing impingement of the outflow graft.The ptfe graft was removed.One year after pump exchange and removal of the ptfe graft, the patient is without further complications.

• Brand Name: GORE TEX VASCULAR GRAFT (LINED)
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: craig bearchell ; 1500 n. 4th street; 9285263030
• MDR Report Key: 9955467
• MDR Text Key: 188315397
• Report Number: 2017233-2020-00244
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K802095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• 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): Other
• Patient Age: 54 YR