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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC¿ VALVE (MITRAL); HEART-VALVE, NON-ALLOGRAFT TISSUE
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ABBOTT MEDICAL EPIC¿ VALVE (MITRAL); HEART-VALVE, NON-ALLOGRAFT TISSUE Back to Search Results
Catalog Number E100-27M
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Dyspnea (1816)
Event Date 11/13/2023
Event Type  Injury  
Event Description
It was reported that on (b)(6) 2020, a 27mm epic mitral valve was implanted in a patient.On (b)(6) 2023, the valve failure discovered, the patient has shortness of breath with movement.On (b)(6) 2020, the valve was explanted.Upon explant, there was pannus observed on the valve.The patient is stable.
 
Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.
 
Manufacturer Narrative
Explant of the device due to stenosis and pannus was reported.The device was received for investigation which found that there was fibrous thickening on cusps 1 and 3.The majority of the cusp tissue was previously removed or torn.There was pannus on the outflow of cusp 3 which was limited to the sewing cuff.Folds/retractions were present in cusp 1.No 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.The pannus reported could have contributed to the stenosis reported, however with the majority of the tissue not being present for analysis this could not be confirmed.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
 
Manufacturer Narrative
Explant of the device due to stenosis and pannus was reported.The device was received for investigation which found that there was fibrous thickening on cusps 1 and 3.The majority of the cusp tissue was previously removed or torn.There was pannus on the outflow of cusp 3 which was limited to the sewing cuff.Folds/retractions were present in cusp 1.No 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.The pannus reported could have contributed to the stenosis reported, however with the majority of the tissue not being present for analysis this could not be confirmed.There is no indication of a product quality issue with regards to manufacture, design, or labeling.It was reported that on (b)(6) 2020, a 27mm epic mitral valve was implanted in a patient.On (b)(6) 2023, the valve failure discovered, the patient has shortness of breath with movement.On (b)(6) 2023, the valve was explanted.Upon explant, there was pannus observed on the valve.The patient is stable.
 
Event Description
N/a.
 
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Brand Name
EPIC¿ VALVE (MITRAL)
Type of Device
HEART-VALVE, NON-ALLOGRAFT TISSUE
Manufacturer (Section D)
ABBOTT MEDICAL
5050 nathan lane n
plymouth MN 55442
Manufacturer (Section G)
ST. JUDE MEDICAL LTDA. REG#3001883144
1301rua profvieira demendonça
bairro engenho nogueira 31.31 0-26
BR   31.310-260
Manufacturer Contact
karen krouse
5050 nathan lane n
plymouth, MN 55442
6517565400
MDR Report Key18377329
MDR Text Key331175751
Report Number2135147-2023-05670
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,Followup
Report Date 02/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberE100-27M
Device Lot Number6796456
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/26/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/30/2022
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;
Patient Age68 YR
Patient SexFemale
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