MAUDE Adverse Event Report: ST. JUDE MEDICAL CANADA, INC. 27MM TRIFECTA VALVE IDE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TF-27A-IDE

Device Problem Missing Information (4053)

Patient Problems Aortic Insufficiency (1715); Edema (1820); High Blood Pressure/ Hypertension (1908); No Information (3190)

Event Date 11/04/2018

Event Type  Injury  

Event Description

On (b)(6) 2008, a 27mm trifecta valve was implanted as part of the us ide study.On (b)(6) 2018, structural dysfunction was reported in the 10-year old valve.On (b)(6) 2018, a valve-in-valve procedure was completed with an unknown valve.The patient is reported stable.Additional information has been requested.(clinical study patient id: (b)(6)).

Manufacturer Narrative

Events of aortic insufficiency with pulmonary hypertension were reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined, however, information from the field indicated that the 27mm trifecta valve had been implanted for 10 years.

Event Description

On (b)(6) 2008, a 27mm trifecta valve was implanted as part of the us ide study.Concomitantly, a double coronary artery bypass and primary closure of patent foramen ovale was completed.On (b)(6) 2018, the patient presented with shortness of breath and peripheral edema.Echo observed normal left ventricular function with an ejection fraction of 58%, and severe aortic insufficiency with pulmonary hypertension.Blood cultures showed no bacterial growth.The patient was treated with antibiotics for six weeks.On (b)(6) 2018, a valve-in-valve procedure was completed within the 10-year-old 27mm trifecta valve with a 26mm edwards sapien 3.The patient is reported stable.(clinical study patient id: (b)(6)).

• Brand Name: 27MM TRIFECTA VALVE IDE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL CANADA, INC.; 2550 blvd. vanier; st. hyacinthe J2S 6 L7; CA J2S 6L7
• MDR Report Key: 8098026
• MDR Text Key: 128180861
• Report Number: 8020430-2018-00023
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2009
• Device Model Number: TF-27A-IDE
• Device Catalogue Number: TF-27A-IDE
• Device Lot Number: 0002661383
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention