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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM; HEART-VALVE, NON-ALLOGRAFT TISSUE
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ST. JUDE MEDICAL, INC. EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM; HEART-VALVE, NON-ALLOGRAFT TISSUE Back to Search Results
Model Number E100-27M
Device Problems Backflow (1064); Material Split, Cut or Torn (4008)
Patient Problems Dyspnea (1816); Endocarditis (1834); Unspecified Infection (1930); Aortic Valve Insufficiency/ Regurgitation (4450)
Event Date 12/09/2021
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
 
Event Description
It was reported on (b)(6) 2015, a 27mm epic stented porcine heart valve w/flexfit system was implanted.On (b)(6) 2021, the patient was hospitalized due to cardiac insufficiency and an infection was confirmed and the patient was prescribed antibiotics.The patient was experiencing shortness of breath and mitral regurgitation was noted.On (b)(6) 2021, the valve was explanted and upon explant all 3 leaflets were torn.Two leaflets tear was observed along the commissures and one leaflet remained had become torn from the central part.There was no vegetation noted on the valve.An non-abbott valve was successfully implanted.The patient was reported to be in stable condition.
 
Event Description
It was reported on (b)(6) 2015, a 27mm epic stented porcine heart valve w/flexfit system was implanted.On (b)(6) 2021, the patient was hospitalized due to cardiac insufficiency and an infection was confirmed and the patient was prescribed antibiotics.The patient was experiencing shortness of breath and mitral regurgitation was noted.On (b)(6) 2021, the valve was explanted and upon explant all 3 leaflets were torn.Two leaflets tear was observed along the commissures and one leaflet remained had become torn from the central part.There was no vegetation noted on the valve.An non-abbott valve was successfully implanted.The patient was reported to be in stable condition.
 
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
 
Manufacturer Narrative
Explant was reported due to mitral regurgitation and all three cusps were noted to be torn upon explant, with degenerative changes and loss of collagen in the tissue present at the tear sites.The investigation confirmed that all three leaflets were torn and had degenerative changes to the tissue.There was fibrous pannus ingrowth on the inflow and outflow surface of cusp 1.Cusp 1 and 2 contained microcalcifications.No acute inflammation was present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the tears could not be conclusively determined; however, the degenerative changes noted to the tissue could have contributed to the tear formation and one of the tears was associated with a calcification.
 
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Brand Name
EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM
Type of Device
HEART-VALVE, NON-ALLOGRAFT TISSUE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
177 east county road b
st. paul MN 55117
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.
177 east county road b
st. paul MN 55117
Manufacturer Contact
karen krouse
5050 nathan lane n
plymouth, MN 55442
6517565400
MDR Report Key13053989
MDR Text Key285611462
Report Number3007113487-2021-00121
Device Sequence Number1
Product Code LWR
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P040021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/13/2019
Device Model NumberE100-27M
Device Lot NumberBR00002107
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/14/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age66 YR
Patient SexMale
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