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

Catalog Number UNK EPIC STENTED PORCINE HV

Device Problems Calcified (1077); Degraded (1153); Patient-Device Incompatibility (2682)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 01/01/2011

Event Type  Injury  

Manufacturer Narrative

The udi number is not known as the part and lot numbers were not provided investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on an unknown date of 2011, an unknown epic valve was implanted into the patient.On an unknown date, the patient was hospitalized for heart failure and scheduled for a valve replacement.It is believed that there is structural deterioration of the valve, causing the heart failure.On (b)(6) 2023 the valve was removed from patient anatomy and replaced with a 25mm non-abbott device.It was noted upon explanation that the valve was not deteriorated.

Manufacturer Narrative

Additional information: b5, g3, g6, h2, h6, h10 an event of hospitalization for heart failure due to mitral stenosis was reported.Information from the field indicated that pannus and calcification were observed on the explanted valve.There was no allegation against the abbott device but the field did believe the reported event was due to the degradation of the valve.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device was not returned for analysis.Based on the information received, the reported stenosis is consistent with structural valve deterioration (svd), specifically fibro-calcific svd (fcsvd), which is a well-known complication of tissue heart valve replacement surgery.A variety of factors may contribute to svd, including patient, biological, and implant related factors.However, the presence of the reported biological factors which can result in stenosis such as calcification (from patient conditions predisposing to elevated calcium like renal disease etc.), immobilizing thrombus, or pannus formation reducing the valve diameter also could not be confirmed as the valve was not returned for histopathological examination.There is no indication of a product quality issue with regards to manufacture, design, or labelingh6 device code 1153 removed.

Event Description

It was reported that on an unknown date of 2011, an unknown epic valve was implanted into a patient in the mitral position.On an unknown date, the patient was hospitalized for heart failure due to mitral stenosis and scheduled for a valve replacement.It is believed that there is structural deterioration of the valve, causing the heart failure.On (b)(6)2023 the valve was removed from patient anatomy and replaced with a 25mm non-abbott device.It was noted upon explanation that the valve was not deteriorated but pannus and calcification was observed.

• 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: 16744210
• MDR Text Key: 313337323
• Report Number: 2135147-2023-01658
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 11/13/2023
• 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; Hospitalization