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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Renal Failure (2041); Complete Heart Block (2627)

Event Date 06/08/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Reference manufacturer report: 3001883144-2020-00104.The article "patient-prosthesis mismatch worsens long-term survival ¿ insights from the finnvalve registry" that was accepted on june 8, 2020 was reviewed.This research article is a retrospective multi center experience to investigate the incidence of patient-prosthesis mismatch (ppm) and its impact on survival and reinterventions in a finnish nationwide cohort.Edwards perimount magna ease, abbott trifecta, sorin soprano, sorin crown, sorin mitroflow, abbott epic/biocor, medtronic hancock ii, medtronic mosaic were associated to the study.The article concluded that severe ppm was associated with significantly increased risk of late all-cause mortality.The primary author of the article is sebastian dahlbacka, md, phd of heart and lung center, helsinki university hospital, helsinki with the corresponding email sebastian.Dahlbacka@hus.Fi.

Manufacturer Narrative

As reported in a research article, complications from having a tissue valve implanted include patient-prothesis mismatch, aortic valve replacement, bleeding, and acute kidney injury.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: TRIFECTA STENTED TISSUE VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (SH); 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: 10738510
• MDR Text Key: 213220577
• Report Number: 3008452825-2020-00589
• 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,health professional,l
• Type of Report: Initial,Followup
• Report Date: 12/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR