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

Model Number CVD0027

Device Problem Biocompatibility (2886)

Patient Problems Death (1802); Complete Heart Block (2627)

Event Date 02/27/2020

Event Type  Death  

Manufacturer Narrative

Investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2020, a portico valve was selected for implant.Post - implantation, the valve migrated into the ascending aorta.The physician attempted to snare the valve but was unsuccessful.A valve replacement was planned and the patient was reported to be stable.Patient had replacement surgery with a trifecta valve on (b)(6) 2020.On (b)(6) 2020, the patient expired after she had an av-block.Cpr was attempted but was not successful.The physician reported that the av-block and death event are unrelated to the implanted trifecta valve or the implant procedure.

Manufacturer Narrative

An event of patient death after an av-block 6 days after valve replacement with a trifecta valve was reported.A more comprehensive assessment could not be performed since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined, however the physician reported that the death was not due to the valve or the implant procedure.

• Brand Name: TRIFECTA STENTED TISSUE 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 01897 -405; CS 01897-4050
• MDR Report Key: 9938069
• MDR Text Key: 186997437
• Report Number: 3008452825-2020-00186
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CVD0027
• Device Catalogue Number: CVD0027
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2020
• Initial Date FDA Received: 04/08/2020
• Supplement Dates Manufacturer Received: 05/12/2020
• Supplement Dates FDA Received: 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 76 YR