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

Model Number TF-23A-IDE

Device Problems Microbial Contamination of Device (2303); Torn Material (3024)

Patient Problem Endocarditis (1834)

Event Date 03/21/2017

Event Type  Injury  

Manufacturer Narrative

The results of this investigation concluded that all three leaflets were fibrotically thickened.Tearing was observed in all three leaflets.No evidence was found to suggest the cause of the fibrotic thickening and tearing was due to an intrinsic defect in the valve, as supported by review of the valve's device history record and the analysis performed.The cause of the reported event remains unknown.

Event Description

On (b)(6) 2008, a 23 mm trifecta valve was implanted.On (b)(6) 2017, the patient was admitted to the hospital with suspected valve vegetation.Blood cultures were positive.On (b)(6) 2017, the valve was explanted and replaced with a 25 mm edwards magna valve.The patient was discharged on (b)(6) 2017.(clinical study patient id: (b)(4)).

Event Description

On (b)(6) 2008, a 23 mm trifecta valve was implanted.On (b)(6) 2017, the patient was admitted to the hospital with suspected valve vegetation.Blood cultures were positive.On (b)(6) 2017, an echocardiogram confirmed a leaflet tear.On (b)(6) 2017, the valve was explanted and replaced with a 25 mm edwards magna valve.The patient was discharged on (b)(6) 2017.(clinical study patient id: (b)(6)).

• 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: 6541879
• MDR Text Key: 74355910
• Report Number: 8020430-2017-00008
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/05/2017

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: 10/30/2008
• Device Model Number: TF-23A-IDE
• Device Catalogue Number: TF-23A-IDE
• Device Lot Number: 0002095046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2017
• Initial Date FDA Received: 05/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2007
• 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): Hospitalization; Required Intervention
• Patient Age: 82 YR