MAUDE Adverse Event Report: ST. JUDE MEDICAL CATD SJM MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 25A-101

Device Problem Obstruction of Flow (2423)

Patient Problem Corneal Pannus (1447)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

A case report of bentall surgery for aortic basal enlargement 15 years after konno surgery.Background: the number of patients with adult congenital heart disease (achd) has increased with improvements in surgical outcomes for congenital heart disease, and the number of achd with thoracic aortic aneurysms has also increased.The achd requires attention in the reoperation such as the complicated anatomy and various operative methods for it.Base reoperation after konno operation is difficult due to the high mineralization of the previously used patches.We report a case of konno's operation and ventricular septal occlusion followed by bentall.Case: the case was a (b)(6) man.The patient had a heart murmur immediately after birth and was diagnosed as having left ventricular hypertrophy in the first year of life at high school, who was followed up for vsd and pulmonary artery stenosis.The patient was diagnosed as having aortic valve stenosis by close examination.Percutaneous transluminal angioplasty was performed at the age of 21, but aortic valve insufficiency developed and an konno operation (sjm 25mm) + vsd closure was performed in the same year.Thereafter, it was judged necessary to manage the patient as an adult, and the patient was referred to the outpatient clinic for adult congenital heart disease at the age of 40.A 60-mm ascending aortic aneurysm with dilatation of the base was found by ct performed at that time, and an operation was indicated.Echocardiography showed good left ventricular systolic function, ef 56 %, mr (-), and tr trivia l.Coronary angiography showed no significant stenosis.Surgical findings: after median sternotomy and removal of pericardial adhesions, the patient underwent cardiopulmonary bypass with ascending aortic blood transmission and superior vena cava/inferior vena cava blood removal.Cardiac arrest was achieved by antegrade infusion of cardioplegic solution after aortic cross-clamping of the ascending aorta.The aortic root was dissected and the right ventricle outflow tract was cut, resulting in severe mineralization and total resection.Though the go division replacement method of the machine valve preservation was also considered, the mechanical valve was extracted, since the pannus was recognized in the prosthetic valve left ventricle side and the valve seat was covered with the granulation tissue, and the fisting of the prosthetic tube blood was bad, and the hemorrhage was feared.Carefully created left and right coronary artery buttons patches that generate the ventricular septum were also severely mineralization, so they were excised and reconstructed with double bovine pericardium, followed by base reconstruction with on-x 25mm, valsalva graft 30mm.Reconstruction of the right ventricle outflow tract was performed using the bovine pericardium, but it was relatively easy to wean from the cardiopulmonary bypass, which required caution because the suture line was close to the pulmonary valve.However, the operation time for which hemostasis was difficult was 635 minutes.The cardiopulmonary bypass time was 420 minutes, the cardiac arrest time was 314 minutes, and the hemorrhage was 1300ml.Postoperative course: the patient was weaned from the ventilator l pod, started drinking water and eating, and was discharged from the room icu on 2pod.There was no abnormal opinion of aortic valve and base, and there was no problem on ct, so the patient left hospital.Discussion: as in the present case, a strong mineralization was observed in the distant stage in which the ventricular septum reconstruction and the right ventricle outflow path reconstruction were reconstructed in the equine autologous pericardium, and it was difficult to manipulate to the base.Surgery for aortic root enlargement of the achd requires a tenuous understanding of the primary operation and a reliable aortic root reoperation surgical.

Manufacturer Narrative

An event of explant due to pannus was reported.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

A case report of bentall surgery for aortic basal enlargement 15 years after konno surgery background: the number of patients with adult congenital heart disease (achd) has increased with improvements in surgical outcomes for congenital heart disease, and the number of achd with thoracic aortic aneurysms has also increased.The achd requires attention in the reoperation such as the complicated anatomy and various operative methods for it.Base reoperation after konno operation is difficult due to the high mineralization of the previously used patches.We report a case of konno's operation and ventricular septal occlusion followed by bentall.Case: the case was a 40-year-old man.The patient had a heart murmur immediately after birth and was diagnosed as having left ventricular hypertrophy in the first year of life at high school, who was followed up for vsd and pulmonary artery stenosis.The patient was diagnosed as having aortic valve stenosis by close examination.Percutaneous transluminal angioplasty was performed at the age of 21, but aortic valve insufficiency developed and an konno operation (sjm 25mm) + vsd closure was performed in the same year.Thereafter, it was judged necessary to manage the patient as an adult, and the patient was referred to the outpatient clinic for adult congenital heart disease at the age of 40.A 60-mm ascending aortic aneurysm with dilatation of the base was found by ct performed at that time, and an operation was indicated.Echocardiography showed good left ventricular systolic function, ef 56 %, mr (-), and tr trivia l.Coronary angiography showed no significant stenosis.Surgical findings: after median sternotomy and removal of pericardial adhesions, the patient underwent cardiopulmonary bypass with ascending aortic blood transmission and superior vena cava/inferior vena cava blood removal.Cardiac arrest was achieved by antegrade infusion of cardioplegic solution after aortic cross-clamping of the ascending aorta.The aortic root was dissected and the right ventricle outflow tract was cut, resulting in severe mineralization and total resection.Though the go division replacement method of the machine valve preservation was also considered, the mechanical valve was extracted, since the pannus was recognized in the prosthetic valve left ventricle side and the valve seat was covered with the granulation tissue, and the fisting of the prosthetic tube blood was bad, and the hemorrhage was feared.Carefully created left and right coronary artery buttons patches that generate the ventricular septum were also severely mineralization, so they were excised and reconstructed with double bovine pericardium, followed by base reconstruction with on-x 25mm, valsalva graft 30mm.Reconstruction of the right ventricle outflow tract was performed using the bovine pericardium, but it was relatively easy to wean from the cardiopulmonary bypass, which required caution because the suture line was close to the pulmonary valve.However, the operation time for which hemostasis was difficult was 635 minutes.The cardiopulmonary bypass time was 420 minutes, the cardiac arrest time was 314 minutes, and the hemorrhage was 1300ml.Postoperative course: the patient was weaned from the ventilator l pod, started drinking water and eating, and was discharged from the room icu on 2pod.There was no abnormal opinion of aortic valve and base, and there was no problem on ct, so the patient left hospital.Discussion: as in the present case, a strong mineralization was observed in the distant stage in which the ventricular septum reconstruction and the right ventricle outflow path reconstruction were reconstructed in the equine autologous pericardium, and it was difficult to manipulate to the base.Surgery for aortic root enlargement of the achd requires a tenuous understanding of the primary operation and a reliable aortic root reoperation surgical.

• Brand Name: SJM MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 9553812
• MDR Text Key: 173885811
• Report Number: 2648612-2019-00110
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25A-101
• Device Catalogue Number: 25A-101
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR