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

Model Number TF-25A

Device Problem Leak/Splash (1354)

Patient Problem Aortic Insufficiency (1715)

Event Date 10/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2011, a 25 mm trifecta valve was implanted.On (b)(6) 2016, the valve was explanted due to aortic insufficiency and replaced with a 23 mm edwards perimount valve.At the time of the aortic explant procedure, the surgeon identified mitral insufficiency with calcification and a concomitant mvr was performed.A 31 mm epic mitral valve (s/n: (b)(4) ) was implanted in the mitral annulus.The patient is reported to be recovering.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL BRASIL LTDA.; caixa postal 106; belo horizonte 34000 -000; BR 34000-000
• Manufacturer (Section G): ST. JUDE MEDICAL BRASIL LTDA.; caixa postal 106; belo horizonte 34000 -000; BR 34000-000
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6151046
• MDR Text Key: 61622559
• Report Number: 3001743903-2016-00052
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100029
• 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
• Report Date: 11/21/2016

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: 06/27/2013
• Device Model Number: TF-25A
• Device Catalogue Number: TF-25A
• Device Lot Number: 3460038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2016
• Initial Date FDA Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2009
• 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: 71 YR