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

Catalog Number UNK EPIC STENTED PORCINE HV

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Renal Failure (2041)

Event Date 05/01/2011

Event Type  Injury  

Manufacturer Narrative

The udi number is not known as the part and lot numbers were not provided.Summarized patient outcomes/complications of elderly taiwanese patients who underwent transcatheter aortic valve replacement or surgical aortic valve replacement in different risk groups were reported in a research article, "one-year and five-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement in a taiwanese elderly population" in a subject population with multiple co-morbidities including heart failure, syncope, angina, mitral regurgitation, diabetes mellitus, dyslipidemia, atrial fibrillation, pacemaker, chronic obstructive pulmonary disorder, smoker, prior stroke, uremia, cancer, peripheral arterial occlusive disease, coronary artery disease, prior myocardial infarction, coronary artery bypass graft, prior percutaneous coronary intervention, prior cardiac surgery.Some of the complications reported were bleeding, stroke, pacemaker implant (surgical intervention), acute kidney injury, rehospitalization; these complications are anticipated for the procedure and subject population.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.

Event Description

The article, "one-year and five-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement in a taiwanese elderly population", was reviewed.The article presented a retrospective, single center study to provide real-world data on outcomes for elderly taiwanese patients who underwent transcatheter aortic valve replacement or surgical aortic valve replacement in different risk groups.Devices included in this study were medtronic corevalve, edward sapien, cryolife on-x, carpentier-edwards perimount magna ease, and abbott/st.Jude epic.The article concluded that taiwan elderly patients in all risk groups did not have significant differences in mortality rates between the tavi and the savr group.However, the tavi group had shorter hospital stay and higher rate of paravalvular leakage in all risk groups.[the primary and corresponding author was yung-szu wu, cardiovascular center, taichung veterans general hospital, taichung 407219, taiwan, with corresponding email: adconvert98@gmail.Com].The time frame of the study was from (b)(6)2011 through (b)(6) 2021.A total of 177 patients were included in this study, of which it was not confirmed how many received an abbott device (epic is considered part of savr group which accounts for 75 out of 177 patients).The average age was 80.2 years and the average gender was female.Comorbidities included heart failure, syncope, angina, mitral regurgitation, diabetes mellitus, dyslipidemia, atrial fibrillation, pacemaker, chronic obstructive pulmonary disorder, smoker, prior stroke, uremia, cancer, peripheral arterial occlusive disease, coronary artery disease, prior myocardial infarction, coronary artery bypass graft, prior percutaneous coronary intervention, prior cardiac surgery.

• Brand Name: EPIC¿ VALVE (AORTIC)
• Type of Device: 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: 18615460
• MDR Text Key: 334219954
• Report Number: 2135147-2024-00433
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK EPIC STENTED PORCINE HV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening; Disability