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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 Problems Calcified (1077); Patient Device Interaction Problem (4001); Device Stenosis (4066)
Patient Problems Mitral Valve Stenosis (1965); Thrombosis/Thrombus (4440)
Event Date 12/15/2022
Event Type  Injury  
Event Description
It was reported that on (b)(6) 2014, a 27mm epic valve was successfully implanted in a mitral valve replacement procedure.On an unknown date, postoperative mitral stenosis (ms) was noted to have progressed.On (b)(6) 2022, the device was explanted in a non-emergent procedure and another 27mm epic valve was used as a replacement.The explanted valve appeared hardened by thrombus or calcification.There was no tear observed on the explanted valve.The patient was reported as stable.No additional information was provided.
 
Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
 
Manufacturer Narrative
Explant of the valve due to stenosis was reported.The investigation found that outflow thrombus was present on all three cusps.Calcifications were present on cusp 1 and 3.There was a think layer of fibrin on the inflow surface of all three cusps.No inflammation was present on the valve.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The thrombus and calcification found on the valve could have contributed to the reported stenosis.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
 
Event Description
It was reported that on (b)(6) 2014, a 27mm epic valve was successfully implanted in a mitral valve replacement procedure.On an unknown date, postoperative mitral stenosis (ms) was noted to have progressed.On (b)(6) 2022, the device was explanted in a non-emergent procedure and another 27mm epic valve was used as a replacement.The explanted valve appeared hardened by thrombus or calcification.There was no tear observed on the explanted valve.The patient was reported as stable.No additional information was provided.Subsequent to the initially filed report, the following information was received that the mitral stenosis was confirmed because of patient symptoms.Specific patient symptoms were not provided.
 
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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 #3014918977
edificio #44 calle 0, ave. 2
el coyol alajuela 1897- 4050
CS   1897-4050
Manufacturer Contact
karen krouse
5050 nathan lane n
plymouth, MN 55442
6517565400
MDR Report Key16153223
MDR Text Key307259962
Report Number2135147-2023-00185
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 04/11/2023
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 Date10/27/2017
Device Catalogue NumberE100-27M
Device Lot Number4555329
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/21/2022
Initial Date FDA Received01/12/2023
Supplement Dates Manufacturer Received04/07/2023
Supplement Dates FDA Received04/11/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/28/2013
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;
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