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 #2017233-2020-00244, #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.An 18mm ptfe shield graft was placed around the outflow graft during lvad (left ventricular assist device) placement.The patient presented 23 months after implantation with dyspnea and dark-colored urine.Computed tomography angiography (cta) of the chest indicated partial obstruction of the outflow graft beginning at the anastomosis of the outflow graft with the ascending aorta and extending over a length of 5cm proximally.To avoid redosternotomy and pump exchange, a percutaneous approach was planned.A single ld mega 12x36 stent was deployed in the distal portion of the outflow graft.Following the stenting procedure, there was minimal improvement in lvad flows, and lactate dehydrogenase (ldh) levels continued to rise.Computed tomography angiography (cta) revealed residual stenosis of the outflow graft proximal to the stent.Five additional overlapping ld mega 12x36 stents were deployed along the length of the outflow graft, resulting in normalization of lvad flows.

• 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: 9955517
• MDR Text Key: 193699640
• Report Number: 2017233-2020-00245
• 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
• Is this a Product Problem Report?: No
• 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: 36 YR