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 Non specific EKG/ECG Changes (1817); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The article, "a case of impaired right coronary artery blood flow associated with aortic wound following prosthetic valve placement", was reviewed.The article presented a case study of a 60-year-old female patient with severe aortic stenosis due to a bicuspid valve.It was reported that on an unknown date, a 21mm epic valve was chosen for implant.After the valve was implanted and the aorta clamp was released, no spontaneous heart beat was observed.Transesophageal echocardiography confirmed hypokinesia of the right ventricle and st elevation was observed on electrocardiogram (ecg) ii lead.It was revealed the right coronary artery had become strained toward the sutured area.It was reported the operator had previously avoided a calcified lesion while suturing the valve during the implant procedure.A decision was made to place the patient back on cardiopulmonary bypass (cpb) and the calcification was removed before the aorta was closed again.After the aorta clamp was removed, the heart beat was restored and right ventricle function improved.The patient was weaned from cpb and administered catecholamine.[the primary author was yasuka hatahira, nagoyatokushukai general hospital, aichi, japan].

Manufacturer Narrative

As reported in a research article, a case of impaired right coronary artery blood flow associated with aortic wound following prosthetic valve placement.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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: 18185400
• MDR Text Key: 328739503
• Report Number: 2135147-2023-05128
• 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: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• 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: 11/22/2023
• 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
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 41 KG