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

Model Number	E100-27M-00
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Arrhythmia (1721); Fatigue (1849); Pain (1994); Heart Block (4444)
Date of Event	01/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2023, a 27mm epic valve was successfully implanted in a patient.On (b)(6) 2023, the patient returned to the hospital due to complaints of fatigue and back pain.A full work up and echocardiography determined that there was a thickening or an unusual finding on one of the valve's leaflets.There was no treatment reported due to this event.No patient consequences were reported.
Event or Problem Description
It was reported that on (b)(6) 2023, a 27mm epic valve was selected for implanted in a patient with severe dyspnea with limited exertion, dense mitral annular calcification and severe calcific mitral stenosis.The patient was heparinized completely and the act was confirmed to be over 400.The 27mm epic valve was implanted in a supraannular fashion.A concomitant procedure was performed using a 40mm non abbott device to occluded the left atrial appendage.The patient was weaned off cardiopulmonary bypass without difficulty.Repeat transesophageal echocardiogram showed well functioning prosthesis, no paravalvular leak and no change in the left ventricle function.There was minimal gradient across the bioprosthetic valve.The procedure was tolerated well and the patient was transferred into the intensive care unit in critical but stable condition.The patient experience confusion and agitation for two days post operatively.The patient was moving all extremities on command and heart rhythm was sinus rhythm with atrioventricular block.On post operative day three, the patient experienced supraventricular tachycardia and was started on an amiodarone drip.Patient was seen by psychiatry and was started on zyprexa, which showed mild improvement with the patient's confusion.The patient was discharged on (b)(6) 2023.On (b)(6) 2023, the patient returned to the hospital due to complaints of fatigue and back pain.Patient had ongoing abdominal pain since surgery with lower back pain radiating to the front.A full work up and echocardiography determined that there was a thickening or an unusual finding on one of the valve's leaflets.There was no treatment reported due to this event.
Additional Manufacturer Narrative
An event of confusion, agitation, atrioventricular block, supraventricular tachycardia, fatigue and back pain was reported.A returned device assessment, to see if there were any valve abnormalities, could not be performed as the device remains implanted and was not returned for analysis.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)
• Common Device Name: 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: 16436543
• Report Number: 2135147-2023-00655
• Device Sequence Number: 3199382
• Product Code: LWR
• UDI-Device Identifier: 05414734055574
• UDI-Public: 05414734055574
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2023

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
• Operator of Device: Health Professional
• Device Model Number: E100-27M-00
• Device Catalogue Number: E100-27M-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female