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

Model Number	EMAX-19
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Stroke/CVA (1770); Fatigue (1849); Movement Disorder (4412); Thrombocytopenia (4431)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Clinical information: (b)(6) - sh device registry, patient site id: (b)(6).It was reported that on (b)(6) 2025, a 19mm epic max valve was successfully implanted in a patient.There was no difficulty experienced implanting the 19mm epic max valve.On (b)(6) 2025, it's noted that the patient suffered and ischemic stroke to the posterior inferior cerebellar artery.There were multiple lacunar lesions.It's noted that the patient had developed atrial fibrillation prior to the ischemic stroke.The patient was receiving subtherapeutic doses of low-molecular-weight heparin.The patient reported some weakness.A brain computed tomography scan confirmed the ischemic stroke.The patient motor function have begun to improve, but the patient is still recovering.Analysis of the medical history revealed that the patient improved clinically on post-operative day 16, becoming much more alert, although still had difficulty walking without assistance.The patient did not experience a permanent injury or disability, with their condition having gradually improved.The patient was hospitalized for a total of 22 days.The cause of the patient's atrial fibrillation is attributed to the patient age, comorbidities, and the implant procedure.The cause of the patient's stroke is uncertain, but the atrial fibrillation is believe to be a contributing factor.There is no allegation of malfunction against the abbott device or procedure.The patient was discharged at the time of report.
Additional Manufacturer Narrative
An event of ischemic stroke, weakness and movement disorder were reported after successful implant of epic valve without any implanting difficulty.The patient had developed atrial fibrillation prior to the ischemic stroke.Also reported that there were multiple lacunar lesions.The device remains implanted and will not be returned to abbott.The device history record was 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 atrial fibrillation was attributed to the patient age, comorbidities, and the implant procedure.The atrial fibrillation may have contributed to the reported ischemic stroke.However, the exact cause of reported event could not be determined.The patient effects of weakness and movement disorder appear to be cascading effects of stroke.The unexpected medical intervention is due to patient receiving subtherapeutic doses of low-molecular-weight heparin.The patient was reported to be hospitalized for a total of 22 days.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Additional Manufacturer Narrative
An event of ischemic stroke, weakness and movement disorder were reported after successful implant of epic valve without any implanting difficulty.The patient had developed atrial fibrillation prior to the ischemic stroke.Also reported that there were multiple lacunar lesions.The patient developed thrombocytopenia (<20,000) and anti-heparin antibodies were confirmed.The device remains implanted and will not be returned to abbott.The device history record was 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 atrial fibrillation was attributed to the patient age, comorbidities, and the implant procedure.The atrial fibrillation may have contributed to the reported ischemic stroke.However, the exact cause of reported event could not be determined.The patient effects of weakness and movement disorder appear to be cascading effects of stroke.The unexpected medical intervention is due to patient receiving subtherapeutic doses of low-molecular-weight heparin.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
Clinical information: (b)(6).It was reported that on (b)(6) 2025, a 19mm epic max valve was successfully implanted in a patient.There was no difficulty experienced implanting the 19mm epic max valve.On 14 april 2025, it's noted that the patient suffered and ischemic stroke to the posterior inferior cerebellar artery.There were multiple lacunar lesions.It's noted that the patient had developed atrial fibrillation prior to the ischemic stroke.The patient was receiving subtherapeutic doses of low-molecular-weight heparin.The patient reported some weakness.A brain computed tomography scan confirmed the ischemic stroke.The patient motor function have begun to improve, but the patient is still recovering.The patient was switched to fondaparinux due to suspected heparin induced thrombocytopenia.Despite this, the patient developed thrombocytopenia (<20,000) and anti heparin antibodies were confirmed.Analysis of the medical history revealed that the patient improved clinically on post-operative day 16, becoming much more alert, although still had difficulty walking without assistance.The patient did not experience a permanent injury or disability, with their condition having gradually improved.The patient was hospitalized for a total of 22 days.The cause of the patient's atrial fibrillation is attributed to the patient age, comorbidities, and the implant procedure.The cause of the patient's stroke is uncertain, but the atrial fibrillation is believe to be a contributing factor.There is no allegation of malfunction against the abbott device or procedure.The patient was discharged at the time of report.No additional information was provided.
Event or Problem Description
Clinical information: (b)(6) device registry, patient site id: (b)(6) ((b)(6),(b)(6)) it was reported that on (b)(6) 2025, a (b)(6) epic max valve was successfully implanted in a patient.There was no difficulty experienced implanting the 19mm epic max valve.On (b)(6)2025, it's noted that the patient suffered and ischemic stroke to the posterior inferior cerebellar artery.There were multiple lacunar lesions.It's noted that the patient had developed atrial fibrillation prior to the ischemic stroke.The patient was receiving subtherapeutic doses of low-molecular-weight heparin.The patient reported some weakness.A brain computed computed tomography scan confirmed the ischemic stroke.The patient motor function have begun to improve, but the patient is still recovering.The patient was switched to fondaparinux due to suspected heparin induced thrombocytopenia.Despite this, the patient developed thrombocytopenia ((b)(6)) and anti heparin antibodies were confirmed.Analysis of the medical history revealed that the patient improved clinically on post-operative day 16, becoming much more alert, although still had difficulty walking without assistance.The patient did not experience a permanent injury or disability, with their condition having gradually improved.The patient was hospitalized for a total of 22 days.The cause of the patient's atrial fibrillation is attributed to the patient age, comorbidities, and the the implant procedure.The cause of the patient's stroke is uncertain, but the atrial fibrillation is believe to be a contributing factor.There is no allegation of malfunction against the abbott device or procedure.The patient was discharged at the time of report.
Additional Manufacturer Narrative
An event of ischemic stroke, weakness and movement disorder were reported after successful implant of epic valve without any implanting difficulty.The patient had developed atrial fibrillation prior to the ischemic stroke.Also reported that there were multiple lacunar lesions.The patient developed thrombocytopenia ((b)(6)) and anti-heparin antibodies were confirmed.The device remains implanted and will not be returned to abbott.The device history record was 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 atrial fibrillation was attributed to the patient age, comorbidities, and the implant procedure.The atrial fibrillation may have contributed to the reported ischemic stroke.However, the exact cause of reported event could not be determined.The patient effects of weakness and movement disorder appear to be cascading effects of stroke.The unexpected medical intervention is due to patient receiving subtherapeutic doses of low-molecular-weight heparin.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: EPIC MAX VALVE (AORTIC)
• 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 LTDA. REG#3001883144; 1301rua profvieira demendonça; bairro engenho nogueira 31.31 0-26; BR 31.310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22203738
• Report Number: 2135147-2025-03184
• Device Sequence Number: 6765118
• Product Code: LWR
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/30/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: EMAX-19
• Device Catalogue Number: EMAX-19
• Device Lot Number: BR00041802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 06/30/2025; 03/24/2026; 06/12/2026
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 07/11/2025; 04/17/2026; 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2023
• 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: Disability; Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 173 LB