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

Model Number TF-25A

Device Problems Calcified (1077); Insufficient Information (3190)

Patient Problems Dyspnea (1816); Pleural Effusion (2010); Renal Failure (2041)

Event Date 05/06/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2011, a 25mm trifecta valve was implanted.On (b)(6) 2020, the patient presented with dyspnea.On an unknown date a valve in valve was performed.Patient status is unknown.Additional information is pending.

Manufacturer Narrative

Additional information: b5, h6.

Event Description

Additional information: on (b)(6) 2011, a 25mm trifecta valve was implanted.On (b)(6) 2020, the patient presented with dyspnea.On (b)(6) 2020, date a valve in valve was performed due to calcification.Patient was reported to in stable condition.On (b)(6) 2020, a pleural effusion and renal failure was reported and the patient received dialysis however, this is not related to the 21mm trifecta valve.

Manufacturer Narrative

Additional information: h6.An event of dyspnea, and replacement of the valve with a valve-in-valve due to calcification was reported.A more comprehensive assessment could not be performed as a valve-in-valve procedure was performed and the device was not accessible for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 10110842
• MDR Text Key: 193403470
• Report Number: 3001883144-2020-00054
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052047
• UDI-Public: 05414734052047
• Combination Product (y/n): N
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2013
• Device Model Number: TF-25A
• Device Catalogue Number: TF-25A
• Device Lot Number: 3386849
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/08/2020
• Initial Date FDA Received: 06/02/2020
• Supplement Dates Manufacturer Received: 06/04/2020; 07/20/2020
• Supplement Dates FDA Received: 06/04/2020; 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 122