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

Model Number TF-19A

Device Problem Biocompatibility (2886)

Patient Problems Aortic Regurgitation (1716); Mitral Regurgitation (1964); Tricuspid Regurgitation (2112)

Event Date 08/02/2019

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The investigation results will be provided in a subsequent submission.

Event Description

In 2016, an double valve replacement procedure and a tricuspid annuloplasty were conducted.On (b)(6) 2019, the patient was referred to the hospital for heart failure.The patient was noted to have aortic regurgitation, mitral regurgitation and tricuspid regurgitation.On (b)(6) 2019, a re-do dvr and tap were performed and both valves were replaced with mechanical valves (serial number unknown).The physician reported endocarditis and pannus on the right coronary cusp.Since the procedure was performed at another hospital, the physician is unable to determine if the reported event was due to the initial procedure or patient condition.Additional information has been requested.

Manufacturer Narrative

Explant was reported due to aortic regurgitation.The investigation found that all three leaflets were fibrotically thickened.No vegetations, thrombi, calcifications or acute inflammation were present.Basophilic foreign material, consistent with surgical material and presumed to be procedure related, were present on the surface of leaflet 3.The cause of the reported event could not be conclusively determined.

Event Description

In 2016, an double valve replacement procedure and a tricuspid annuloplasty were conducted.On (b)(6) 2019, the patient was referred to the hospital for heart failure.The patient was noted to have aortic regurgitation, mitral regurgitation and tricuspid regurgitation.On (b)(6) 2019, a re-do dvr and tap were performed and both valves were replaced with mechanical valves (serial number unknown).The physician reported endocarditis and pannus on the right coronary cusp.Since the procedure was performed at another hospital, the physician is unable to determine if the reported event was due to the initial procedure or patient condition.

• 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: 8945598
• MDR Text Key: 155986461
• Report Number: 3008452825-2019-00436
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TF-19A
• Device Catalogue Number: TF-19A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 40