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

Model Number CVD0039

Device Problems Backflow (1064); Perivalvular Leak (1457); Obstruction of Flow (2423)

Patient Problems Aortic Regurgitation (1716); Heart Failure (2206); Valvular Stenosis (2697)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, a mechanical valve was explanted due to paravalvular leakage, regurgitation, stenosis, and pannus.The patient also had symptoms of hemolytic anemia and heart failure.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

Title: a case of repeated bentall konno surgical for paravalvular regurgitation after konno surgery with aortic base enlargement.Summary: background: the konno operation was announced in 1975 to expand the aortic valve annulus and implant an appropriately sized prosthetic valve for children with small aortic valve annulus or subaortic stenosis.However, reoperation cannot be completely avoided even after an adequately-sized prosthetic valve has been implanted by konno's operation, septoplasty by the second konno method may be required in the reoperation.[case] a (b)(6) man was admitted to our hospital.For aortic valve and subvalvular stenosis after aortic arch reconstruction for aortic arch transection and ventricular positive defect closure, 30 the patient had a history of konno operation (23-mm sj m mechanical valve) and was referred to our hospital for evaluation and treatment of symptoms of hemolytic anemia and heart failure.Echocardiography revealed paravalvular leakage with moderate to severe aortic regurgitation, pannus around the mechanical valve, moderate left ventricular outflow tract stenosis, and moderate right ventricle outflow tract stenosis.Cardiac catheterization revealed severe mineralization of aortic root and ventricular septal patches, left ventricular outflow tract pressure gradient of 46 mmhg, right ventricle outflow tract pressure gradient of 55 mmhg, mild mechanical valve leaflet malfunction, and severely dilated aortic root (60mm).Chest ct revealed severe mineralization, retraction right ventricle outflow tract patches, and a highly enlarged aortic root.It was diagnosed as the adaptation of aorta go division replacement with aortic valve re-replacement and right ventricle outflow tract stenosis release from them.[surgical] the re-operation was carried out under recurrent median sternal incision and use of cold heart-lung machine.After aortic cross-clamping, the ascending aorta was transected and coronary artery boutons were harvested, resulting in ambient mineralization of patches at the time of konno operation and massive pannus growth around the mechanical valve.The mechanical valve was partially detached from the interventricular septal patches at the time of the konno operation, and it seemed to be paravalvular leakage.The mechanical valve and older patch were totally resected with minimal anastomoses to the ventricular septum, and ventricular septum plasty and aortic valve annulus dilatation by the konno technique were repeated with the bovine pericardial patch (redo-konno).A composite graft made of a 25-mm on-x mechanical valve and a 28-mm valsalva sinus prosthesis was attached to the re-expanded aortic valve annulus, and aortic root replacement was performed by holding coronary artery boutons.Finally, bovine pericardial patches attached to the interventricular septum were inverted and attached to the right ventricle outflow tract to expand the right ventricle outflow tract, and the operation was completed.The patient was extubated on the day after surgery, and the patient was discharged from the icu room on the postoperative day 2.The patient was discharged from the hospital on the 23rd postoperative day.Postoperative echocardiography revealed good aortic mechanical valve function, no paravalvular leakage, and no left ventricular outflow tract stenosis, and contrast-enhanced computed tomography showed a well-reconstructed aortic root.At present, the ambulatory is being carried out.Conclusion: the bentall konno reoperation method seemed to be an excellent method for paravalvular leakage or similar conditions with go enlargement after konno operation.

• Brand Name: SJM MECHANICAL HEART VALVE (UNKNOWN)
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9539044
• MDR Text Key: 173499764
• Report Number: 2648612-2019-00111
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CVD0039
• Device Catalogue Number: CVD0039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2019
• 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: 39 YR