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

Model Number TF-19A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Mitral Insufficiency (1963); Heart Failure (2206)

Event Date 06/21/2018

Event Type  Death  

Manufacturer Narrative

It was reported that in (b)(6) 2018, the patient presented with aortic bioprosthesis degeneration and cardiac decompensation with pulmonary edema from dialysis.The patient expired in (b)(6) 2019 due to heart failure.The results of the investigation are inconclusive since 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 at the time of commercialization.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 in a (b)(6) year old female.On (b)(6) 2018, the patient presented with mitral insufficiency and aortic bioprosthesis degeneration in addition to cardiac decompensation with a pulmonary edema from dialysis.No intervention was performed and the patient was treated with medication.Per the site, the relationship to the device was unconfirmed.Information received on 26 june 2019 indicates that on (b)(6) 2019, the patient was reported to have expired due to heart failure.Of note, the site does not attribute the death to the previously reported adverse event.(clinical study patient id: (b)(6)).

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8828146
• MDR Text Key: 152246535
• Report Number: 3008452825-2019-00351
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2013
• Device Model Number: TF-19A
• Device Catalogue Number: TF-19A
• Device Lot Number: 3297581
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2011
• 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
• Patient Age: 73 YR
• Patient Weight: 88