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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 E100-31M
Device Problem Degraded (1153)
Patient Problem Heart Failure/Congestive Heart Failure (4446)
Event Date 09/05/2023
Event Type  Injury  
Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that on (b)(6) 2015, a 31mm stented porcine,mit,epic was implanted in a patient.On the day (b)(6) 2023, the heart team of the hospital reviewed their diagnostic reports and acknowledged that the patient was suffering for mitral bioprosthesis dysfunction which resulted in severe heart failure and increased antegrade gradient.On (b)(6) 2023, the patient underwent a percutaneous valve in valve procedure that ended well.The patient is stable.
 
Event Description
It was reported that on (b)(6) 2015, a 31mm stented porcine,mit,epic was implanted in a patient.On the day 05 september 2023, the heart team of the hospital reviewed their diagnostic reports and acknowledged that the patient was suffering for mitral bioprosthesis dysfunction which resulted in severe heart failure and increased antegrade gradient.On (b)(6) 2023, the patient underwent a percutaneous valve in valve procedure that ended well.The patient is stable.
 
Manufacturer Narrative
An event of patient suffering from mitral bio-prosthesis dysfunction that resulted in severe heart failure and increased antegrade gradient after 8 years of implant was reported.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device remains implanted and was not returned for analysis.No implant related factors could be confirmed from the information received from the field as information related to implant procedure was not provided.The device history record was also reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
 
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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 Key17976462
MDR Text Key326164585
Report Number2135147-2023-04592
Device Sequence Number1
Product Code LWR
Combination Product (y/n)N
Reporter Country CodeIT
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 11/20/2023
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? Yes
Device Operator Health Professional
Device Expiration Date11/24/2018
Device Catalogue NumberE100-31M
Device Lot Number4914871
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/28/2023
Initial Date FDA Received10/20/2023
Supplement Dates Manufacturer Received11/01/2023
Supplement Dates FDA Received11/20/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/25/2014
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 Age69 YR
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