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 Problem Thrombosis/Thrombus (4440)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

As reported through a abstract article, "a case of transesophageal echocardiography in which membrane-like constructs reciprocating the replacement valve during heart-lung prosthesis weaning was eliminated during observation but not embolism", a 19mm epic valve was chosen for implant for a 70-year-old female patient with severe aortic stenosis.Cardiopulmonary bypass (cpb) was established by right femoral artery/vein approach.The valve was implanted in a supra position with non-everting mattress sutures.Then, the patient was weaned off of cpb, it was noticed there was a 2cm sized object seen traveling to and from the left ventricle to the aorta.No aortic regurgitation caused by the object was confirmed.It was determined that re-aortal cross clamping and surgical intervention to remove the object was too invasive.A decision was made to wean the patient from cpb but it was reported right after that decision, the object suddenly became not visible under transesophageal echocardiography.After post-procedure, there was no report of paralysis of extremities after the patient woke up and the patient was extubated four hours later.During the entire hospitalization stay, there was no neurological disturbances or organ damage caused by embolization.The patient status was reported stable and discharged on the ninth post-operative day.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.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The article, "a case of transesophageal echocardiography in which membrane-like constructs reciprocating the replacement valve during heart-lung prosthesis weaning was eliminated during observation but not embolism", was reviewed.The article presented a case study of a 70-year-old female patient with severe aortic stenosis.It was reported that on an unknown date, a 19mm epic valve was chosen for implant.Cardiopulmonary bypass (cpb) was established by right femoral artery/vein approach.The valve was implanted in a supra position with non-everting mattress sutures.It was then reported as the patient was weaned off of cpb, it was noticed there was a 2cm sized object seen traveling to and from the left ventricle to the aorta.No aortic regurgitation caused by the object was confirmed.It was determined that re-aortal cross clamping and surgical intervention to remove the object was too invasive.A decision was made to wean the patient from cpb but it was reported right after that decision, the object suddenly became not visible under transesophageal echocardiography.There was no change observed in either regional cerebral oxygen saturation or hemodynamic status.Three hours post-procedure, there was no report of paralysis of extremities after the patient woke up and the patient was extubated four hours later.During the entire hospitalization stay, there was no neurological disturbances or organ damage caused by embolization.The patient status was reported stable and discharged on the ninth post-operative day.[the primary author was maki akiyama, ayase heart hospital, tokyo, japan].

• 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: 18171705
• MDR Text Key: 328550814
• Report Number: 2135147-2023-05085
• 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
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• 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: 10/31/2023
• 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): Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 55 KG