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

Model Number TF-23A

Device Problems Gradient Increase (1270); Torn Material (3024)

Patient Problem Pulmonary Edema (2020)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2013, a 23 mm trifecta valve (serial unknown) was implanted.During a follow-up visit in (b)(6) 2016, the patient presented with a fever, pulmonary edema and a high pressure gradient.On (b)(6) 2016, the valve was explanted and replaced with a 23 mm perimount valve.During explant, a leaflet tear was noted on the trifecta valve.The patient has been discharged.

Manufacturer Narrative

The results of this investigation concluded leaflet 2 contained tears.There was a thin layer of fibrin on all three leaflets.No acute inflammation or calcifications were present in the valve.A review of the device history record was not possible since the serial number was unavailable.There was no evidence found to suggest the cause of the fibrin and tears were due to an intrinsic defect in the valve, as supported by the analysis performed.The cause of the reported event remains unknown.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (CVD); 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 (CVD); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6124357
• MDR Text Key: 60787186
• Report Number: 3008452825-2016-00163
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: 60 YR