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

Device Problem Occlusion Within Device (1423)

Patient Problems Death (1802); Dyspnea (1816); Stenosis (2263); Aortic Dissection (2491)

Event Date 05/03/2011

Event Type  Injury  

Event Description

In a literature article it was reported that a (b)(6) male with a history of smoking and aortic valve replacement in 1995, presented with dyspnea on exertion which began in 2010.In (b)(6) 2011, the dyspnea progressed to appear during even low levels of exertion.Echocardiogram detected prosthetic aortic valve stenosis with an ejection fraction of 50%.The patient underwent aortic valve replacement in may 2011.During surgery, the patient had an aortic dissection with loss of both coronary ostia as a complication.Aortic valve replacement was performed and a bentall and bono procedure was implemented to reconstruct the aorta.The orifices of the coronary ostia were covered by the aortic tube and additional revascularization was performed by placing a saphenous vein graft to the right coronary artery and a 5 mm gore-tex® vascular graft to the left main (the cabrol procedure).After 48 hours of surgery, due to persisting hemodynamic instability, the patient was taken to the cath lab to check the status of both coronary grafts.It was stated that an angiogram showed a diffuse stenosis of the gore-tex® vascular graft to the left main starting at the site of the coronary aorta-anastomosis with impaired distal flow around the left coronary system.An emergency percutaneous intervention to rescue the cabrol graft was successfully performed.The patient was hemodynamically stable after the procedure and was extubated two weeks post procedure.Unfortunately the patient expired 2 months after the procedure due to an infectious lung disease.

Manufacturer Narrative

History of smoking, aortic valve replacement in 1995, dyspnea on exertion which began in 2010.No lot number information was supplied; therefore, no review of the manufacturing paperwork could be performed.The device remained implanted; consequently, a direct product analysis was not possible.Without additional information it is impossible to further investigate this event.

Manufacturer Narrative

Additional information: literature citation: gonzález j, peña duque m, larraga m.Early stenosis in a gore-tex graft connected to the left main: an emergency transradial angioplasty for a complication in a cabrol procedure.J invasive cardol 2012, 24(10):539-542.

• Brand Name: GORE TEX® VASCULAR GRAFT
• 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: sandra whicker ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4419112
• MDR Text Key: 5278623
• Report Number: 2017233-2015-00021
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K802095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/20/2015

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: Not provided
• Initial Date FDA Received: 01/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/20/2015
• 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): Required Intervention
• Patient Age: 67 YR