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

Model Number TF-23A

Device Problem Insufficient Information (3190)

Patient Problems Arrhythmia (1721); Infarction, Cerebral (1771)

Event Date 07/02/2014

Event Type  Injury  

Manufacturer Narrative

An event of ischemic brain infarction and low left ventricle ejection fraction 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) 2010, a 23mm trifecta valve was implanted.On (b)(6) 2014, the patient was seen due to repeated short visual disturbances which were the result of paroxysmal af resulting in cardio-embolic episodes.The patient was sent home the same day.On (b)(6) 2017, the patient had left sided pressure while walking.The patient was diagnosed with ischemic brain infarction (parenchymal changes in the supply area of the inferior cerebellar artery posterior left).Since (b)(6) 2017, the patient has been treated with amiodarone.On (b)(6) 2017, the patient was diagnosed with lvef of 16%.The physician attributes the low lvef to pre-existing heart disease.A non-abbott (boston scientific, momentem g124) cardiac resynchronization therapy defibrillator (crt-d) was attempted to be implanted on (b)(6) 2017 but failed.Reimplantation of the lv electrode occurred on (b)(6) 2017.The event is on-going.No abnormalities of the valve have been reported however the physician cannot rule out the valve.(clinical study patient id: (b)(6)).

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7265621
• MDR Text Key: 99874764
• Report Number: 3007113487-2018-00005
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2012
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Device Lot Number: 3173989
• Other Device ID Number: 05414734052030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2010
• 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: 62 YR
• Patient Weight: 77