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

Catalog Number UNK EPIC STENTED PORCINE HV

Device Problem Perivalvular Leak (1457)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 11/01/2023

Event Type  Injury  

Manufacturer Narrative

D4 - 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.Na.

Event Description

It was reported that on (b)(6) 2018, a 31mm epic valve was successfully implanted in a patient.On 01 november 2023, it was noted that the 31mm epic valve had a perivalvular leak (pvl), the patient was suffering from heart failure and cardiac cachexia.The decision was made to attempt a pvl closure using two amplatzer valvular plug 3, but they could not be deployed in a stable configuration due to being excessively small, and were removed without detaching them from the delivery cable.Another two amplatzer vascular plug 2 were attempted for the pvl closure, were deployed, but were not stable and embolized into the patient's abdominal aorta.The two embolized amplatzer vascular plug 2 had to be snared.After successful removal of the plugs, the decision was made to implant three amplatzer septal occluder for closure of the perivalvular leak.On (b)(6) 2023, it was noted that there was significant hemolysis and the patient returned for implant of an additional amplatzer vascular plug 2.

Event Description

It was reported that on (b)(6) 2018, a 31mm epic valve was successfully implanted in a patient.On (b)(6) 2023, it was noted that the 31mm epic valve had a perivalvular leak (pvl), the patient was suffering from heart failure and cardiac cachexia.The decision was made to attempt a pvl closure using two amplatzer valvular plug 3, but they could not be deployed in a stable configuration due to being excessively small, and were removed without detaching them from the delivery cable.There was no other issue with the amplatzer valvular plugs 3 other than mis-sizing.Another two amplatzer vascular plug 2 were attempted for the pvl closure, were deployed, but were not stable and embolized into the patient's abdominal aorta.The two embolized amplatzer vascular plug 2 had to be snared.After successful removal of the plugs, the decision was made to implant three amplatzer septal occluder for closure of the perivalvular leak.On (b)(6) 2023, it was noted that there was significant hemolysis and the patient returned for implant of an additional amplatzer vascular plug 2.The cause of the pvl of the 31mm epic valve is attributed to annular calcification with poor tissue integrity.

Manufacturer Narrative

An event of paravalvular leak and heart failure was reported.A returned device assessment could not be performed as the device was not returned for analysis.Information from the field indicated that the patient had class iv heart failure and cardiac cachexia prior to the implant procedure.An epic valve was implanted and leak was observed.The implanting physician believe caused the perivalvular leak of the epic valve was due to annular calcification with poor tissue integrity (patient conditions).Based on available information, the cause of the reported event appears to be related to patient conditions.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 18527510
• MDR Text Key: 333048236
• Report Number: 2135147-2024-00270
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• 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: 04/01/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Required Intervention