MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC STENTED PORCINE HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	E100-27M-00
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Codes	Adult Respiratory Distress Syndrome (1696); Cardiac Arrest (1762); Dyspnea (1816); Mitral Valve Stenosis (1965); Pulmonary Edema (2020); Heart Failure/Congestive Heart Failure (4446)
Date of Event	10/13/2022
Type of Reportable Event	Death
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 21 october 2021, a 21mm non-abbott aortic valve and a 27mm epic mitral valve were successfully implanted in a double valve replacement surgery.On (b)(6) 2022, the patient was admitted to the hospital for shortness of breath worsening on exertion, progressive respiratory distress, and pulmonary edema.The patient had a transesophageal echocardiogram to evaluate the mitral valve prosthesis and left ventricular function.The mean gradient of the mitral valve was 21mmhg, which was classified as severe mitral stenosis.The peak inflow velocity was 284 cm/sec.The doppler velocity index (dvi) was 2.9.The effective orifice area (eoa) was 0.5 cm^2.The mitral valve pressure half time was 229 ms.During pre-operative work-up while the patient was hospitalized, the patient was intubated due to respiratory distress, and the patient went into cardiac arrest post intubation.The cause of death was pulseless electrical activity (pea).The patient died on (b)(6) 2022.No additional information was provided.
Additional Manufacturer Narrative
An event of shortness of breath worsening on exertion, progressive respiratory distress, pulmonary edema, severe mitral stenosis, and death was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications information from the field indicated that the gradient level was higher than anticipated and that patient comorbidities included hypertension, hyperlipidemia, chronic kidney disease (likely stage 3).It was indicated that the patient was diagnosed with acute heart failure prior to the valve operation.Biological factors such as calcification (from patient conditions predisposing to elevated calcium like renal disease), immobilizing thrombus, or pannus formation reducing the valve diameter which could contribute to device stenosis could not be confirmed as the valve was not returned for histopathological examination.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.
Event or Problem Description
It was reported that on (b)(6) 2021, a 21mm non-abbott aortic valve and a 27mm epic mitral valve were successfully implanted in a double valve replacement surgery.On (b)(6) 2022, the patient was admitted to the hospital for shortness of breath worsening on exertion, progressive respiratory distress, and pulmonary edema.The patient had a transesophageal echocardiogram to evaluate the mitral valve prosthesis and left ventricular function.The mean gradient of the mitral valve was 21mmhg, which was classified as severe mitral stenosis.The peak inflow velocity was 284 cm/sec.The doppler velocity index (dvi) was 2.9.The effective orifice area (eoa) was 0.5 cm^2.The mitral valve pressure half time was 229 ms.During pre-operative work-up while the patient was hospitalized, the patient was intubated due to respiratory distress, and the patient went into cardiac arrest post intubation.The cause of death was pulseless electrical activity (pea).The patient died on (b)(6) 2022.Subsequent to the initially filed report, the following information was received that: the patient had aortic stenosis prior to receiving the 21mm non-abbott valve.On (b)(6) 2022 the patient was admitted to the (b)(6) medical center with significant left ventricular hypertrophy and a 14mm gradient across the epic mitral valve.Echo findings determined there was mitral stenosis.The patient was managed medically and discharged.During preparation for the valve operation that was set to occur prior to the patient death, the patient was diagnosed with acute heart failure.

• Brand Name: EPIC STENTED PORCINE HEART VALVE
• 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: 15857898
• Report Number: 2135147-2022-02211
• Device Sequence Number: 20464474
• Product Code: LWR
• UDI-Device Identifier: 05414734055574
• UDI-Public: 05414734055574
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2023

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 Expiration Date: 02/17/2025
• Device Model Number: E100-27M-00
• Device Catalogue Number: E100-27M-00
• Device Lot Number: BR00028060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2022
• Supplement Date Received by Manufacturer: 01/29/2023
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 01/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2021
• 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: Death
• Patient Age: 72 YR
• Patient Sex: Male