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

Model Number	ESP200-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Pneumonia (2011); Pulmonary Edema (2020); Renal Failure (2041); Heart Block (4444)
Date of Event	12/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical information: crd_1032 - sh device registry, patient site (b)(6)- (b)(4).It was reported that on (b)(6) 2025, a 15mm epic plus supra valve was implanted in the patient.After the procedure, the patient had a heart block and pacing was needed.The patient was returned back to sinus rhythm.During the early postoperative phase due to post-implant edema/swelling in the annular region causing conduction problems ¿ resolved after edema regression without the need for intervention.The patient had pneumonia and treated with antibiotics.During the postoperative course, potentially due to hypovolemia resulting in temporary acute on chronic (mild) kidney failure.Pneumonia occurred due to superinfection and clinical symptoms.On (b)(6) 2026, the patient presented with a paroxysmal atrial fibrillation (af) and got treated with amiodarone and betablocker.Five days after the procedure, the patient had an acute kidney injury and treated with volume replacement.The patient was reported discharged.
Additional Manufacturer Narrative
An event of heart block, pneumonia, acute kidney injury, pulmonary edema and atrial fibrillation was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.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 pneumonia occurred due to superinfection and clinical symptoms.Field indicated that the patient had conduction disturbances during the early postoperative phase due to post-implant edema/swelling in the annular region and resolved without the need for intervention.The exact cause of reported patient effects cannot be conclusively determined.The unexpected medical interventions resulted from medication administered for pneumonia and atrial fibrillation, and temporary pacing required due to heart block.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: EPIC¿ SUPRA 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: 25225599
• Report Number: 2135147-2026-03406
• Device Sequence Number: 18592300
• Product Code: LWR
• UDI-Device Identifier: 05415067033147
• UDI-Public: (01)05415067033147(17)290615
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 05/19/2026

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: ESP200-25
• Device Catalogue Number: ESP200-25
• Device Lot Number: BR00053269
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2025
• 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: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 87 KG