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 Arrhythmia (1721); Stroke/CVA (1770); Heart Block (4444)

Event Type  Death  

Event Description

It was reported that through a research article identifying sjm epic valves that may be related to a death or serious injury.Specific patient information is documented as a total 42 patients who received the sjm epic stented porcine heart valve during a mitral valve replacement.Of the 42 patients, 21 patients were women, and the average age was 75 years old.Of the total 42 procedures conducted, 22 cases were single valve replacements, 19 cases were double valve replacements, and 1 case was a triple valve replacement.This research article is a prospective single center experience to evaluate the mid-term results of the mitral valve replacements with the sjm epic stented porcine heart valve.Operative death occurred in 1 patient (2.4%) who underwent simultaneous surgery with left ventricular assist device (lvad) brace for ischemic cardiomyopathy (icm).Complications included permanent pacer implantation in 4 patients (sick sinus syndrome in 3 patients and atrioventricular block in 1 patient) without left ventricular rupture.Survivorship by kapl an-meier was 94% at 1 year, 91% at 3 years, and 82% at 5 years, with no cardiovascular mortality.Major cerebro-cardiovascular event avoidance was 94% at 5 years, events were cerebral infarction in 1 patient, and permanent pacer implantation in 1 patient (sick sinus syndrome).There were no late reoperations and no structural valve deterioration (defined as mitral valve area (mva) < 1.5cm^2 and mean pg > 5 or mitral regurgitation (mr) > moderate).

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

Summarized patient outcomes/complications of epic valve were reported in a research article in a subject population with single valve replacements, double valve replacements and triple valve replacement.Some of the complications reported were permanent pacer implantation, sick sinus syndrome, atrioventricular block, low cardiac output syndrome, cerebral infarction and death of patient who underwent simultaneous surgery with left ventricular assist device brace for ischemic cardiomyopathy; 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.B2: date estimated d4: the udi number is not known as the part and lot number were not provided.B2:outcomes attributed to ae corrected to death d1: brand name corrected h1: report type corrected to death.

• 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 01897 -405; CS 01897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16021450
• MDR Text Key: 305874602
• Report Number: 2135147-2022-02659
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2023

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?: 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
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 03/15/2023
• Supplement Dates FDA Received: 03/15/2023
• 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; Death
• Patient Age: 75 YR
• Patient Sex: Female