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

Catalog Number E100-33M-00

Device Problems Use of Device Problem (1670); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Thrombosis/Thrombus (4440)

Event Date 09/15/2023

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) 2021, a 33mm epic mitral valve was implanted in a patient.On an unknown date, the patient presented with stroke and it was noted that the valve was caught up in the papillary muscles.The physician thought it was oversized because the patient was small and annulus and ventricle were small.There were pannus on the valve and also damage to the ventricular wall from the valve.On (b)(6) 2023, the valve was explanted and a new 29mm epic mitral valve was implanted.

Event Description

It was reported that on (b)(6) 2021, a 33mm epic mitral valve was implanted in a patient during a mitral valve replacement.On (b)(6) 2023, patient was admitted in the hospital.On an unknown date, the patient presented with stroke and it was noted that the valve was caught up in the papillary muscles.The valve did not migrate.The physician thought it was oversized because the patient was small and the annulus and ventricle were small.There was pannus on the valve and the valve stent post scarred over the ventricular wall.On 15 september 2023, the valve was explanted.In the explanted valve, it was noted that the scar tissue and pannus overgrowth prevented normal leaflet function and lead to thrombosis.A new 29mm epic mitral valve was implanted.

Manufacturer Narrative

An event of patient presenting with a stroke and the valve being caught up in the papillary muscles was reported.Information from the field indicated that the physican thought that the valve may have been oversized and that there was also damage to the ventricular wall from the valve.The field also indicated that scar tissue and pannus overgrowth prevented normal leaflet function and lead to thrombosis.Biological factors which can result in stenosis such as calcification (from patient conditions predisposing to elevated calcium like renal disease etc.), immobilizing thrombus, or pannus formation reducing the valve diameter also could not be confirmed as the valve was not returned for histopathological examination.Abbott requested but did not receive any information from the field about the patient's medical history and predisposition to the factors cited above.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.

• 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: 17916277
• MDR Text Key: 325444665
• Report Number: 2135147-2023-04464
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734055611
• UDI-Public: 05414734055611
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2023
• Device Catalogue Number: E100-33M-00
• Device Lot Number: BR00023093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2019
• 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: 72 YR
• Patient Sex: Female