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

Model Number	EMAX-21
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pneumothorax (2012); Cardiac Tamponade (2226)
Date of Event	02/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
Clinical information: (b)(6) - sh device registry, patient site id: (b)(6).It was reported that on (b)(6) 2026, a 21mm epic max valve was chosen for a procedure.Post procedure, left apical pneumothorax was noted.After the implant, the patient presented with cardiac tamponade and requiring re-sternotomy.A bleeding was noted in the aortotomy area and a blood transfusion was performed.The reason for post operative apical pneumothorax probably due to accidental interoperative opening of the right pleura.They kept pleural drainage tube paved intraoperatively for one more day.
Additional Manufacturer Narrative
An event of cardiac tamponade, pneumothorax and bleeding was reported.A returned device assessment could not be performed as the device 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 available information, the root cause of the reported events could not be conclusively determined.Procedural factors may have contributed to the reported tamponade; however, this cannot be confirmed.The reported pneumothorax and bleeding appear to be related to reported cardiac tamponade.The reported surgical and unexpected medical intervention were results of case-specific circumstances as blood transfusion was performed.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)(4) - sh device registry, patient site id: (b)(6)) it was reported that on (b)(6) 2026, a 21mm epic max valve was chosen for a procedure.Post procedure, left apical pneumothorax was noted.Preoperative activated clotting time (act) was 106.Heparin was administered at 300 iu/kg.After the implant, in the operating room, the patient presented with cardiac tamponade and requiring re-sternotomy.A bleeding was noted in the aortotomy area and a blood transfusion was performed.The reason for post operative apical pneumothorax probably due to accidental interoperative opening of the right pleura.Final act was 126.Baseline international normalized ratio (inr) was 1.08.It was not measured intraoperatively.Postoperatively, it was around 1.36¿1.20.In the most recent lab test on (b)(6) 2026, the inr was 1.10.The bleeding from the aortotomy, which was reinforced with additional sutures.The patient also had a fibrinogen and platelet deficiency.They kept pleural drainage tube paved intraoperatively for one more day.

• 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: 24562683
• Report Number: 2135147-2026-01526
• Device Sequence Number: 9495684
• Product Code: LWR
• UDI-Device Identifier: 05415067045447
• UDI-Public: (01)05415067045447(17)290709
• 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: 2026
• 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
• Report Date (Section B): 04/29/2026

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-21
• Device Catalogue Number: EMAX-21
• Device Lot Number: BR00053320
• 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: 02/13/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2025
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 96 KG