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

Model Number TF-23A-IDE

Device Problems Calcified (1077); Torn Material (3024)

Patient Problems Aortic Insufficiency (1715); Calcium Deposits/Calcification (1758)

Event Date 11/22/2017

Event Type  Injury  

Manufacturer Narrative

An event of aortic insufficiency was 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.

Event Description

On (b)(6) 2009, a trifecta valve was implanted as part of the trifecta ide trial (fda ide#(b)(4)) for aortic insufficiency with a dilated left ventricle secondary to endocarditis.The patient recently developed severe aortic insufficiency (ai) and it was determined necessary to replace the valve.On (b)(6) 2017, a re-do procedure was completed where the valve was explanted and replaced with a 25 mm edwards valve.The trifecta valve was observed to be very calcified and one leaflet was torn causing the ai.The procedure was uneventful and patient has been discharged.The valve was sent to pathology at the hospital and is not expected to be returned for analysis.(clinical study patient id: (b)(4)).

• Brand Name: TRIFECTA TISSUE HEART VALVE
• 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
• Manufacturer (Section G): ST. JUDE MEDICAL CANADA, INC.; 2550 blvd. vanier; st. hyacinthe J2S 6 L7; CA J2S 6L7
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7143146
• MDR Text Key: 95646926
• Report Number: 8020430-2017-00022
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/22/2017

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
• Device Expiration Date: 11/25/2009
• Device Model Number: TF-23A-IDE
• Device Catalogue Number: TF-23A-IDE
• Device Lot Number: 2802849
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2017
• Initial Date FDA Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2008
• 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): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 91