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

Catalog Number E100-27M

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Obstruction/Occlusion (2422); Heart Block (4444); Heart Failure/Congestive Heart Failure (4446); Unspecified Tissue Injury (4559)

Event Date 02/28/2023

Event Type  Injury  

Event Description

The article, "left circumflex artery injury occurring during mitral valve surgery treated successfully with percutaneous intervention in a high surgical and bleeding risk patient", was reviewed.The article presented a case study of a 72-year-old female with a medical history of rheumatic heart disease, mitral valve stenosis, prior percutaneous mitral balloon commissurotomy, and tricuspid regurgitation.It was reported that on an unknown date, a 27mm epic mitral valve was chosen for implant along with a concomitant tricuspid valve annuloplasty with an unknown 28mm ring.After aortic declamping, the patient experienced complete atrioventricular block and a decision was made to implant a ventricular epicardial pacemaker.Cardiopulmonary bypass (cpb) weaning was attempted but transesophageal echocardiogram (tee) revealed poor biventricular mobility and decreased left ventricular ejection fraction of 35 % without paravalvular leaks.The patient was administered dobutamine and norepinephrine, however the patient's symptoms did not improve.The patient was transferred to cardiovascular critical care unit and initial electrocardiogram (ecg) showed right bundle branch block.A second ecg showed a posterior myocardial infarction.Emergency coronary angiography revealed subocclusive lesion in he proximal left circumflex artery probably because of partial mechanical kinking caused by a suture, which compromised flow.A decision was made to perform percutaneous coronary intervention.The patient had a good postoperative course, was discharged from the cardiovascular critical care unit 2 days after pci, and was placed on dual antiplatelet and anticoagulation therapy for 1 month.The article concluded that percutaneous coronary intervention is an option in cases involving kinking of the left circumflex coronary artery after mitral valve replacement and if unable to cross the lesion with a workhorse guidewire, one alternative is to use wires with good support properties and avoid very high tip loads to reduce the risk of perforation.[(b)(6)].

Manufacturer Narrative

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

Manufacturer Narrative

As reported in a research article, left circumflex artery injury occurring during mitral valve surgery treated successfully with percutaneous intervention in a high surgical and bleeding risk patient.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 (MITRAL)
• 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: 18685499
• MDR Text Key: 335191071
• Report Number: 2135147-2024-00602
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: E100-27M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2024
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female