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

Model Number TF-19A

Device Problems Calcified (1077); Torn Material (3024)

Patient Problems Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758)

Event Date 05/17/2018

Event Type  Injury  

Event Description

On (b)(6) 2014, a 19mm trifecta valve was implanted.On (b)(6) 2018, the valve was explanted due to severe aortic stenosis.Upon explant, valve calcification and micro-tears were observed on the leaflet between the right and non-coronary ostia.A medtronic ats open pivot valve was implanted as the replacement.The patient is reported to be recovering.

Manufacturer Narrative

The reported event of valve calcifications and tears were confirmed.Gross morphological and histopathological examination found calcifications and fibrous thickening on all three leaflets.Leaflets 1 and 2 were torn.Incomplete coaptation was observed consistent with the calcified nodules on all three leaflets.Fibrous pannus ingrowth was also observed on the inflow surface of leaflet 3.No acute inflammation was present in the valve.A review of the device history record showed the device met specifications prior to leaving abbott manufacturing facilities.The cause of the reported event remains unknown; however, information from the field indicated that the patient had comorbidities including obesity.

• 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
• MDR Report Key: 7607560
• MDR Text Key: 111295409
• Report Number: 3008452825-2018-00177
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052016
• UDI-Public: 05414734052016
• Combination Product (y/n): N
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/05/2015
• Device Model Number: TF-19A
• Device Catalogue Number: TF-19A
• Device Lot Number: 4219170
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention