MAUDE Adverse Event Report: ST. JUDE MEDICAL / ABBOTT MEDICAL ST. JUDE MEDICAL EPIC VALVE MITRAL VALVE 25MM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number	E100-25M-00
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Heart Failure/Congestive Heart Failure (4446)
Date of Event	07/31/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6).Contact phone number (b)(6).Contact address: (b)(6).History of prosthetic porcine cardiac valve.Due to deterioration of the product, he is requiring increase in medication due to heart failure.Positive for recent hospitalization.Replacement of both the aortic valve and the mitral valve.Paper medical records available with information on each valve.Valve #i st.Jude medical epic valve mitral valve 25mm catalog ii ei00-25m-00, lot# 180424294, exp 2022-03-20.Valve 112 st.Jude medical trifecta valve with glide technology aortic valve 21mm catalog ii tfgt-21a, lot# 16486560, exp 2019-03-13.Placement at (b)(6) hospital of (b)(6) on (b)(6) 2018.Recall on product.Tee results: aortic valve: bioprosthetic av present.Leaflets are mobile.There is moderate transvalve ar.The di is 0.41.At is 92ms.The mg is 28mmh mitral valve: bp mitral valve well seated, no stenosis or regurgitation.Tee reveals: (b)(6) 2023 normal lv and rv function.The bioprosthetic mitral valve is well seated and no stenosis and normal wash out jet.No paravalve leak.The bioprosthetic trifect aortic valve bas mild degeneration changes with no stenosis, however bas moderate ar and also patient prosthesis present.Need to switch to coumadin due to "valvular" afib with local cardiologist.Potential mix-match size per expert opinion.Reference report: mw5120624.

• Brand Name: ST. JUDE MEDICAL EPIC VALVE MITRAL VALVE 25MM
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL / ABBOTT MEDICAL
• MDR Report Key: 17469395
• Report Number: MW5120625
• Device Sequence Number: 12036774
• Product Code: LWR
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Voluntary
• Initial Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date (Section B): 07/26/2023

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 Expiration Date: 03/20/2022
• Device Catalogue Number: E100-25M-00
• Device Lot Number: 180424294
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/04/2023
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMIODARONE 200MG; APIXABAN 5MG; ASPIRIN 325MG; FUROSEMIDE 40MG; KETOCONAZOLE 2% CREAM ; LISINOPRIL 200MG; METOPROLOL 50MG; ROSUVASTATIN 20MG; TRIAMCINOLONE 0.1%
• Outcome Attributed to Adverse Event: Disability; Required Intervention; Life Threatening; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White