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

Model Number TF-25A

Device Problems Backflow (1064); Obstruction of Flow (2423)

Patient Problems Endocarditis (1834); Valvular Stenosis (2697); Aortic Valve Insufficiency/ Regurgitation (4450); Mitral Valve Insufficiency/ Regurgitation (4451); Tricuspid Valve Insufficiency/ Regurgitation (4453); Solid Tumour (4552)

Event Date 06/01/2019

Event Type  Death  

Manufacturer Narrative

An event of endocarditis, stenosis, and aortic regurgitation was reported.A more comprehensive assessment could not be performed as the device was not returned 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.

Event Description

It was reported that on (b)(6) 2011, a 25mm sjm trifecta valve was implanted.On (b)(6) 2019, structural valve deterioration was noted while hospitalized.The patient was hospitalized for left sided weakness which was due to large right side central nervous system (cns) lesion.The hospitalization was prolonged due to progressive neurological deficits and nosocomial infection with enterococcus fascism in blood due to the cns lesion that was complicated by endocarditis.The patient was prescribed antibiotics and methylprednisolone.An echocardiogram was performed on (b)(6) 2019, that noted moderate to severe mitral regurgitation (mr), mild tricuspid regurgitation (tr), the aortic valve was seated well however hemodynamic parameters suggest possible dysfunction/stenosis and moderate to severe aortic regurgitation (ar) was noted.While hospitalized the patient expired on (b)(6) 2019.The primary cause of the patient's death was due to a brain tumor.There was a possibility the valve contributed to the patient's death due to the reported endocarditis, therefore this event is being conservatively reported.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 11879765
• MDR Text Key: 252609816
• Report Number: 3001883144-2021-00059
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052047
• UDI-Public: 05414734052047
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2013
• Device Model Number: TF-25A
• Device Catalogue Number: TF-25A
• Device Lot Number: 3386846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2011
• 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): Death; Hospitalization
• Patient Age: 60 YR
• Patient Weight: 112