Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL SJM TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ST. JUDE MEDICAL SJM TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE Back to Search Results
Model Number TF-27A
Device Problems Stretched (1601); Incomplete Coaptation (2507)
Patient Problems Aortic Regurgitation (1716); Chest Pain (1776); Pulmonary Edema (2020)
Event Type  Injury  
Event Description
On (b)(6) 2015, a 27mm trifecta valve was implanted.On an unknown date, the patient underwent a coronary procedure and developed cardiogenic shock.An echocardiogram was performed which revealed an insufficiency.On (b)(6) 2019, the patient presented to the hospital with angina pain.The patient developed sudden acute decompensation with pulmonary edema and cardiac arrest.The patient was cardioverted and stabilized.On (b)(6) 2019, the device was explanted.Upon explant, it was observed the non-coronary cusp (ncc) was stretched resulting in incomplete coaptation.The valve was intact.The device was replaced with a 25mm magna ease.Postoperatively, the patient was hemodynamically stable, but the patient was slow to wake, agitated, and had difficulty moving their limbs.
 
Manufacturer Narrative
An explant was reported.The investigation found that leaflets 1 and 3 were torn at stent post 1.Information from the field indicated that the valve was torn at explant and was intact when implanted.Fibrous pannus ingrowth was present on the outflow surface of leaflet 2.Leaflet 3 had fibrous thickening.No acute inflammation or significant calcifications were present.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.The cause of the pannus and insufficiency could not be conclusively determined.
 
Event Description
On (b)(6) 2015, a 27mm trifecta valve was implanted.On (b)(6) 2019, the patient presented to the hospital with angina pain and underwent a coronary procedure.Following the coronary procedure, the patient developed cardiogenic shock, acute decompensation with pulmonary edema and cardiac arrest.The patient was cardioverted and stabilized.An echocardiogram was performed which revealed an insufficiency.On (b)(6) 2019, the device was explanted.Upon explant, it was observed the non-coronary cusp (ncc) was stretched resulting in incomplete coaptation.The valve was intact.The device was replaced with a 25mm magna ease.Postoperatively, the patient was hemodynamically stable, but the patient was slow to wake, agitated, and had difficulty moving their limbs.
 
Event Description
On (b)(6) 2015, a 27mm trifecta valve was implanted.On an unknown date, the patient underwent a coronary procedure and developed cardiogenic shock.An echocardiogram was performed which revealed an insufficiency.On (b)(6) 2019, the patient presented to the hospital with angina pain.The patient developed sudden acute decompensation with pulmonary edema and cardiac arrest.The patient was cardioverted and stabilized.On (b)(6) 2019, the device was explanted.Upon explant, it was observed the non-coronary cusp (ncc) was stretched resulting in incomplete coaptation.The valve was intact.The device was replaced with a 25mm magna ease.Postoperatively, the patient was hemodynamically stable, but the patient was slow to wake, agitated, and had difficulty moving their limbs.On an unknown date the patient expired.Additional information has been requested.
 
Manufacturer Narrative
Explant was reported due to "sudden acute decompensation with pulmonary edema and cardiac arrest".Information from the field indicated that two months after valve explant, the patient expired due to drug resistant heart failure.The investigation found that leaflets 1 and 3 were torn at stent post 1.Information from the field indicated that the valve was torn at explant and was intact when implanted.Fibrous pannus ingrowth was present on the outflow surface of leaflet 2.Leaflet 3 had fibrous thickening.No acute inflammation or significant calcifications were present.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.The cause of the insufficiency could not be conclusively determined.
 
Event Description
On (b)(6) 2015, a 27mm trifecta valve was implanted due to severe aortic stenosis with low gradient and depressed ejection fraction.On (b)(6) 2019, the patient underwent a coronary procedure and later developed cardiogenic shock.An echocardiogram was performed which revealed mitral insufficiency and the aortic prosthesis not functioning as intended.On (b)(6) 2019, the patient presented to the hospital with angina pain.The patient developed sudden acute decompensation with pulmonary edema and cardiac arrest.The patient was cardioverted and stabilized.On (b)(6) 2019, the device was explanted.Upon explant, it was observed the non-coronary cusp (ncc) was stretched resulting in incomplete coaptation and calcified.The valve was intact.The device was replaced with a 25mm magna ease.Postoperatively, the patient was hemodynamically stable, but the patient was slow to wake, agitated, and had difficulty moving their limbs.On (b)(6) 2019, the patient expired from drug resistant heart failure.The patient's comorbidities included monovasal coronary artery disease.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SJM TRIFECTA VALVE
Type of Device
HEART-VALVE, NON-ALLOGRAFT TISSUE
Manufacturer (Section D)
ST. JUDE MEDICAL
parque industrial, zona franca coyol s.a.
edificio #44b, calle 0, avenida 2, coyol
alajuela, costa rica 1897- 4050
CS  1897-4050
MDR Report Key8759976
MDR Text Key150002287
Report Number3008452825-2019-00315
Device Sequence Number1
Product Code LWR
UDI-Device Identifier05414734052054
UDI-Public05414734052054
Combination Product (y/n)N
PMA/PMN Number
P100029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 10/02/2019
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 Expiration Date06/07/2016
Device Model NumberTF-27A
Device Catalogue NumberTF-27A
Device Lot Number4673197
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/04/2019
Initial Date FDA Received07/03/2019
Supplement Dates Manufacturer Received07/15/2019
08/08/2019
09/06/2019
Supplement Dates FDA Received08/09/2019
08/28/2019
10/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age84 YR
-
-