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

Model Number TF-23A

Device Problem Device Inoperable (1663)

Patient Problem Pneumonia (2011)

Event Date 06/15/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2011, an aortic valve replacement was performed and this 23 mm sjm trifecta valve was implanted.On (b)(6) 2015, the patient experienced symptoms consistent with left heart insufficiency in the presence of klebsiella pneumonia.It was suspected the suspected cardiac symptoms were due to non-structural dysfunction of the bioprosthesis.The patient was hospitalized, treated with antibiotics and there was reported resolution of the event with non-specific sequelae on (b)(6) 2015.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2011, an aortic valve replacement was performed and this 23 mm sjm trifecta valve was implanted.On (b)(6) 2015, the patient experienced symptoms consistent with left heart insufficiency in the presence of klebsiella pneumonia.It was suspected the cardiac symptoms were due to nonstructural dysfunction of the bioprosthesis resulting in aortic insufficiency.The patient was hospitalized from (b)(6) 2015.During hospitalization, antibiotics were administered and there was reported resolution of the event with non-specific sequelae on (b)(6) 2015.It was reported the patient was in stable condition and refuses any new intervention.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 5417073
• MDR Text Key: 37678696
• Report Number: 3007113487-2016-00021
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2013
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Device Lot Number: 3344240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2011
• 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): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 105