MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC¿ VALVE (MITRAL); HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number E100-29M

Device Problem Degraded (1153)

Patient Problem Insufficient Information (4580)

Event Date 09/21/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

The article, "redo mitral valve replacement using st.Jude medical mechanical prosthesis via transseptal approach in a patient with degenerated mitral epic bioprosthesis: a video presentation", was reviewed.The article presented a case study of a 58-year-old male patient.It was reported that on an unknown date, a 29mm epic valve was implanted in the patient's mitral valve.It was reported 12 years post-procedure on an unknown date, the patient presented with severe bioprosthetic degeneration.A decision was made to reoperate and replace the valve with a 29mm unknown abbott mechanical heart valve.The article concluded that elective institution of cardiopulmonary bypass through femorofemoral arteriovenous cannulation prior to sternotomy prevents accidental injury to the cardiac chambers and great vessels during sternal entry.Pulmonary artery venting and cannulation of the superior vena cava further facilitate dissection of the cardiac chambers without causing injury.Placement of two stay sutures on the prosthetic annulus and intracapsular dissection greatly facilitates explantation without causing rupture of the atrioventricular groove.[the primary and corresponding author was ujjwal kumar chowdhury, all india institute of medical sciences, new delhi, 110029, india, with corresponding e-mail: ujjwalchow@rediffmail.Com].

Manufacturer Narrative

Summarized patient outcomes/complications of epic valve were reported in a research article in a subject population with unknown co-morbidities.Some of the complications reported were surgical intervention, hospitalization and general structural valve deterioration.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.

• 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 Key: 18652645
• MDR Text Key: 334685763
• Report Number: 2135147-2024-00524
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

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 Catalogue Number: E100-29M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2024
• Initial Date FDA Received: 02/06/2024
• Supplement Dates Manufacturer Received: 02/07/2024
• Supplement Dates FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male