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

Model Number TF-19A

Device Problem Perivalvular Leak (1457)

Patient Problems Aortic Insufficiency (1715); Low Blood Pressure/ Hypotension (1914); Septic Shock (2068); Shock (2072); Loss of consciousness (2418); Lethargy (2560)

Event Date 05/15/2015

Event Type  Injury  

Event Description

This 19mm trifecta valve was implanted on (b)(6) 2015.Three months following surgery, the patient presented with mild aortic insufficiency and elevated gradients (65mm hg mean) secondary to a paravalvular leak (pvl).The suspected culprit was either pannus or a thrombus.The patient was hospitalized from (b)(6) 2015 for management of concomitant tachycardia/bradycardia with implantation of a single chamber pacemaker on (b)(6) 2015.During the process of weaning the patient from ventilation, she was noted to be lethargic.Ct and mri scans confirmed an acute cva.Transesophageal echo ((b)(6)) showed a functioning trifecta valve despite turbulent flow.The patient required cardioversion ((b)(6)) for atrial fibrillation.The patient was discharged to an extended care facility ((b)(6)) and the following day ((b)(6)) was found unresponsive.Readmission for hypotension and shock due to digitalis intoxication and sepsis in the presence of multiple co-morbidities was required.Once stabilized, restrictive flow through the trifecta valve was noted with a 48mm residual gradient compatible with patient-prosthesis mismatch.Due to the patient's multiple comorbidities and clinical condition, the decision was made to extubate and transition to hospice care, this occurred on (b)(6).

Manufacturer Narrative

(b)(4).The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with sjm specifications and procedures.As the product was not returned, our investigation was limited to the investigation of the device history records which shows full compliance with specifications.Based on the available information, we were not able to identify a definitive root cause for the event.

• 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 1897 -405; 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 1897 -405; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4866449
• MDR Text Key: 6042947
• Report Number: 3008452825-2015-00041
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/16/2015
• Device Model Number: TF-19A
• Device Catalogue Number: TF-19A
• Device Lot Number: 4146106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2013
• 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