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

Model Number TF-23A

Device Problems Gradient Increase (1270); Material Split, Cut or Torn (4008)

Patient Problems Aortic Regurgitation (1716); Ischemia (1942); Heart Failure (2206)

Event Date 07/03/2019

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2014, a 23mm trifecta valve was implanted in the aortic position.In (b)(6) 2019, the patient presented to the hospital due to cerebrovascular infraction and heart failure.It is unknown if there is correlation to the trifecta valve and the stroke however, a the patient was hospitalized, administrated oxygen, iv fluids and a pacemaker was implanted.The physician believes a tear on one of the trifecta leaflets may have occurred in (b)(6) 2018.In (b)(6) 2019, severe aortic regurgitation (ar) was noted during a routine follow-up.On (b)(6) 2019, a valve in valve procedure was performed and a 26mm medtronic valve was successfully implanted.High gradient was noted.The patient was reported to be stable condition and has been discharged.

Manufacturer Narrative

An event of cerebrovascular infraction, heart failure, aortic regurgitation, and valve replacement with a valve in valve procedure was reported.The results of the investigation are inconclusive since a valve-in-valve procedure was performed and the device was not accessible for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 8878676
• MDR Text Key: 153817691
• Report Number: 3008452825-2019-00379
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052030
• UDI-Public: 05414734052030
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2015
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Device Lot Number: 4282783
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR