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

Model Number	TF-27A
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Endocarditis (1834)
Date of Event	07/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2011, a 27 mm trifecta valve was implanted.The patient was hospitalized from 03 (b)(6) 2018 for dyspnea.On (b)(6) 2018, the patient was diagnosed with endocarditis and medically treated.On (b)(6) 2018, the valve was explanted after treatment of the underlying endocarditis as there was calcification.A 23 mm magna ease valve was implanted in lieu of the trifecta valve.The patient remains in the icu at the time of the last report.(clinical study patient id: (b)(6)).
Additional Manufacturer Narrative
An event of calcification, stenosis, regurgitation and endocarditis was reported.The reported leaflet tear could not be confirmed.The results of the investigation are inconclusive since the device was destroyed by examination at the hospital and therefore not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined; however, information from the field indicated the valve had been implanted for 7.5 years.
Event or Problem Description
On (b)(6) 2011, a 27 mm trifecta valve was implanted.Echocardiograms performed on (b)(6) 2014 and (b)(6) 2015 were normal with no signs of aortic regurgitation and normal aortic valve function.Echocardiogram performed on (b)(6) 2016 demonstrated trace of aortic regurgitation.On (b)(6) 2018, the echo demonstrated moderate aortic regurgitation, moderate aortic valve stenosis, and calcification.The patient was hospitalized from 03 (b)(6) 2018 for dyspnea.An echo performed on (b)(6) 2018, noted severe calcification, moderate aortic valve stenosis (max pg 62 mmhg, mean pg 42 mmhg) and mild regurgitation.No significant valve defects were noted.On (b)(6) 2018, the patient was diagnosed with endocarditis and medically treated.On (b)(6) 2018, the valve was explanted after treatment of the underlying endocarditis as there was calcification.A 23 mm magna ease valve was implanted in lieu of the trifecta valve.The patient is reported to be recovering.The valve was analyzed at the hospital and no endocarditis was noted but a leaflet was almost torn off at the level of the non coronary cusp.The valve will not be returned as it was destroyed by examination at the hospital.(clinical study patient id: (b)(6)).

• Brand Name: SJM TRIFECTA VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL BRASIL LTDA. (NOVA LIMA); caixa postal 106; belo horizonte 34000 -000; BR 34000-000
• MDR Report Key: 7779243
• Report Number: 3001743903-2018-00021
• Device Sequence Number: 13892524
• Product Code: LWR
• UDI-Device Identifier: 05414734052054
• UDI-Public: 05414734052054
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/16/2012
• Device Model Number: TF-27A
• Device Catalogue Number: TF-27A
• Device Lot Number: 3242855
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 95