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

Model Number TF-19A

Device Problem Break (1069)

Patient Problem Pulmonary Edema (2020)

Event Type  Injury  

Event Description

A 19mm trifecta valve was implanted in 2011 due to aortic valve stenosis with pulmonary edema.In march 2015, the patient presented with acute pulmonary edema and a redo avr was required.During the explant procedure, the surgeon observed a cuspal tear and suspected endocarditis.A 19mm non-sjm valve was implanted.The explanted valve was sent for a pathological exam which was negative.In the process of being analyzed for bacteria, the trifecta valve was destroyed by the hospital.

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

In (b)(6) 2015, this trifecta valve implanted 2 1/2 years ago was explanted.Explantation was required as the patient was experiencing acute pulmonary edema.At explant, the surgeon confirmed a cuspal tear.The valve was sent for pathological examination including bacterial testing which was negative.The valve was destroyed in the process of being analyzed at the hospital and will not be returned.

Manufacturer Narrative

Gtin: unknown as serial and lot numbers are unknown.

• Brand Name: TRIFECTA STENTED TISSUE 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 MN 55117 189; CS 55117 1897
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela MN 55117 189; CS 55117 1897
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4730105
• MDR Text Key: 5832342
• Report Number: 3007113487-2015-00021
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/23/2013
• Device Model Number: TF-19A
• Device Catalogue Number: TF-19A
• Device Lot Number: 3415686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention