MAUDE Adverse Event Report: ST. JUDE MEDICAL (CATD-PLYMOUTH) SJM TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TF-19A

Device Problem Leak/Splash (1354)

Patient Problems Aortic Regurgitation (1716); Death (1802); Shock (2072)

Event Date 10/25/2014

Event Type  Injury  

Event Description

The valve was explanted two days postoperatively due to central aortic regurgitation confirmed on echo.A larger, 21mm trifecta valve was implanted.Echo showed normal left ventricular function and normal prosthetic valve function with a gradient of 10mmhg and minor central leak.Six hours post-implant, the patient died due to multi-organ failure and cardiogenic shock.

Manufacturer Narrative

The results of the investigation concluded a scrape was observed on the outflow surface of cusp 3 near the base that was likely the result of handling during the procedure.No other anomalies were observed.There was no evidence found to suggest there was an intrinsic defect in the valve as supported by review of the valve's device history record and the evaluation performed.The cause of the reported central aortic regurgitation resulting in explant remains unknown.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL (CATD-PLYMOUTH); 5050 nathan lane north; edificio #44b, calle 0, avenida 2, coyol; plymouth MN 55442 189
• Manufacturer (Section G): ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA); rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 3131 0-26; BR 31310-260
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4241274
• MDR Text Key: 5012307
• Report Number: 3008452825-2014-00041
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PP100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/22/2016
• Device Model Number: TF-19A
• Device Catalogue Number: TF-19A
• Device Lot Number: 4608044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2014
• 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): Other; Required Intervention
• Patient Age: 87 YR