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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SJM TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE
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ST. JUDE MEDICAL, INC. SJM TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE Back to Search Results
Model Number TF-25A
Device Problems Calcified (1077); Obstruction of Flow (2423)
Patient Problems Aortic Valve Stenosis (1717); Endocarditis (1834); Pulmonary Edema (2020); Heart Failure (2206)
Event Date 03/20/2019
Event Type  Injury  
Manufacturer Narrative
An event of explant due to stenosis was reported.The results of the investigation are inconclusive since the device was not returned 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.Per the site a smaller, 23mm, valve was implanted.
 
Event Description
On (b)(6) 2010, a 25mm trifecta valve was implanted.On (b)(6) 2019, the device was explanted due to stenosis and structural valve deterioration.The device was exchanged for a 23mm medtronic avalus valve.No patient consequences were reported.(clinical study patient id: (b)(6)).
 
Event Description
7 october 2019 jl: additional information was received on 1 october 2019.The patient had a history of severe aortic insufficiency.On (b)(6) 2019, the patient was hospitalized for heart failure and acute pulmonary edema.On (b)(6) 2019, the trifecta valve was explanted and exchanged with a competitor's edwards valve.However, the patient passed away during the re-operation procedure.On (b)(6) 2010, a 25mm trifecta valve was implanted.On (b)(6) 2019, the device was explanted due to stenosis and structural valve deterioration.The device was exchanged for a 23mm medtronic avalus valve.No patient consequences were reported.(clinical study patient id: (b)(6) (b)(4)).
 
Event Description
On (b)(6) 2010, a 25mm trifecta valve was implanted.On (b)(6) 2019, the patient was hospitalized for severe aortic insufficiency likely secondary to endocarditis and atrial fibrillation with quick ventricular response.On (b)(6) 2019, the trifecta valve was explanted and exchanged with a competitor's carpentier edwards valve, which was successfully implanted.The issue was resolved with sequelae of progressive cardiac insufficiency.Abbott received additional information that on 9 july 2019, the patient was hospitalized for heart failure and acute pulmonary edema.On (b)(6) 2019, the patient underwent a second valve exchange to a medtronic avalus and died during this procedure.(clinical study patient id: (b)(6)).
 
Manufacturer Narrative
Explant was reported due to aortic insufficiency, likely secondary to endocarditis, and atrial fibrillation.The investigation found that there was circumferential fibrous pannus ingrowth on both the inflow and outflow surfaces, which narrowed the inflow diameter.All three leaflets were fibrotically thickened.Leaflet 2 contained a fold which caused incomplete coaptation.Calcifications were present of leaflet 2 and 3.Degenerative changes were present in the tissue of leaflet 3.The gram stains were negative for organisms.On leaflets 2 and 3 there was a thin layer of organizing fibrin with acute and chronic inflammation.According to the pathologist, healing or treated endocarditis was not "strongly favored" but could not be entirely ruled out as the cause.Correlation with clinical history would be required to confirm this.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 fold could not be conclusively determined.
 
Event Description
On (b)(6) 2010, a 25mm trifecta valve was implanted.On (b)(6) 2019, the device was explanted due to stenosis and structural valve deterioration.The device was exchanged for a 23mm medtronic avalus valve.No patient consequences were reported.(clinical study patient id: (b)(6).
 
Manufacturer Narrative
(b)(6) 2019 mjr ¿ supplemental report needed to address analysis: d10, h3, h6.Explant was reported due to stenosis and structural valve deterioration.The investigation found that there was circumferential fibrous pannus ingrowth on both the inflow and outflow surfaces, which narrowed the inflow diameter.All three leaflets were fibrotically thickened.Leaflet 2 contained a fold which caused incomplete coaptation.Calcifications were present of leaflet 2 and 3.Degenerative changes were present in the tissue of leaflet 3.The gram stains were negative for organisms.On leaflets 2 and 3 there was a thin layer of organizing fibrin with acute and chronic inflammation.According to the pathologist, healing or treated endocarditis was not "strongly favored" but could not be entirely ruled out as the cause.Correlation with clinical history would be required to confirm.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 formation, fold, calcifications and inflammation could not be conclusively determined.Calcification is a known event associated with tissue heart valves.
 
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Brand Name
SJM TRIFECTA VALVE
Type of Device
HEART-VALVE, NON-ALLOGRAFT TISSUE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
177 east county road b
st. paul MN 55117
MDR Report Key8897436
MDR Text Key154432106
Report Number3007113487-2019-00020
Device Sequence Number1
Product Code LWR
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 10/28/2019
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 Date07/31/2012
Device Model NumberTF-25A
Device Catalogue NumberTF-25A
Device Lot Number3187274
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/17/2019
Initial Date FDA Received08/15/2019
Supplement Dates Manufacturer Received07/17/2019
09/30/2019
09/30/2019
Supplement Dates FDA Received09/18/2019
10/08/2019
10/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death; Hospitalization; Required Intervention;
Patient Age74 YR
Patient Weight119
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