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

Model Number TF-19A

Device Problems Perivalvular Leak (1457); Material Split, Cut or Torn (4008)

Patient Problems Arrhythmia (1721); Dyspnea (1816); Hypothermia (1915); Pleural Effusion (2010)

Event Date 03/11/2020

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 19mm trifecta valve was implanted.On (b)(6) 2020, the patient was hospitalized due to dyspnea, pleural effusion and hyponatremia.A minor paravalvular leak was noted.A pleural puncture was performed and a change in diuretics.The patient was discharged on (b)(6) 2020.The patient was reported to be in stable condition.

Manufacturer Narrative

Additional information: an event of dyspnea, pleural effusion, hyponatremia, and paravalular leak was reported.A more comprehensive assessment could not be performed as the device remains implanted 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

On (b)(6) 2011, a 19mm trifecta valve was implanted.On (b)(6) 2020, the patient was hospitalized due to dyspnea, pleural effusion and hyponatremia.A minor paravalvular leak was noted.A pleural puncture was performed and a change in diuretics.The patient was discharged on (b)(6) 2020.On (b)(6) 2020, the patient presenting with cardiac arrhythmia.The patient was prescribed medication and a ligature atrial appendage was performed.On (b)(6) 2020, a pericardial patch was placed due to thin wall and the trifecta valve was explanted due to a leaflet tear.A 21mm perimount magna ease valve was implanted.On (b)(6) 2020, a plural effusion was reported and a pleurocentesis was performed.On (b)(6) 2020, the patient presented with hyponatremia and patient was started on sodium chloride tablets and was being monitored in the intensive care unit (icu).On (b)(6) the patient was discharged and sent to rehab.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA); rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 10339161
• MDR Text Key: 200825898
• Report Number: 3001883144-2020-00074
• Device Sequence Number: 1
• Product Code: LWR
• 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: 12/08/2020

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: 02/14/2013
• Device Model Number: TF-19A
• Device Lot Number: 3337174
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 07/29/2020
• Supplement Dates Manufacturer Received: 09/28/2020; 11/19/2020
• Supplement Dates FDA Received: 09/30/2020; 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 65