MAUDE Adverse Event Report: ST. JUDE MEDICAL CANADA, INC. TRIFECTA VALVE, IDE, 23MM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TF-23A-IDE

Device Problem Insufficient Information (3190)

Patient Problems Aortic Insufficiency (1715); Congestive Heart Failure (1783)

Event Date 01/13/2017

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2008, a 23mm trifecta valve was implanted.From (b)(6) 2017, the patient was hospitalized for acute heart failure and diagnosed with severe aortic insufficiency.A tavr procedure was required.(clinical study patient id: (b)(6)).

Event Description

From (b)(6) - (b)(6) 2017, the patient was hospitalized for treatment of acute heart failure, pulmonary hypertension and was diagnosed with severe aortic insufficiency and cardiogenic shock.Structural valve deterioration was noted.On (b)(6) 2017, ttes were performed; both noted no evidence of endocarditis; however, the patient was placed on antibiotics secondary to leukocytosis, which was reported to have resolved on (b)(6) 2017.On (b)(6) 2017, an episode of atrial tachycardia requiring cpr was reported.On (b)(6) 2017, a tavr procedure was performed and following the procedure there was improvement in the patient's heart function.The patient was discharged.

• Brand Name: TRIFECTA VALVE, IDE, 23MM
• 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: 6691588
• MDR Text Key: 79227070
• Report Number: 8020430-2017-00010
• 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,Followup
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2008
• Device Model Number: TF-23A-IDE
• Device Catalogue Number: TF-23A-IDE
• Device Lot Number: 0002095027
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2007
• 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