MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM REGENT HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 21AGN-751

Device Problem Leak/Splash (1354)

Patient Problem Aortic Insufficiency (1715)

Event Type  Injury  

Manufacturer Narrative

An event of prolapse of the annulus 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

The following information comes from the abstract of co-existing valvular involvement and complete heart block in churg-strauss syndrome published in "the japanese society for cardiovascular surgery", 2017, vol.46, no.6, p.285-287.At (b)(6), the patient was diagnosed as churg-strauss syndrome (myeloperoxidase anti-neutrophil cytoplasmic antibody: mpo-anca, 74u/ml, crp 12.2 mg/dl).After steroid therapy was started, mpo-anca became negative.During being treated at this hospital as an outpatient, the patient had been controlled in good condition.At (b)(6), an aortic valve replacement (avr) and mitral annuloplasty (map) were performed due to both aortic and mitral regurgitation.This 21 mm regent mechanical heart valve (serial unknown) was implanted in aortic position and a 26 mm cosgrove-edwards annuloplasty ring (edwards lifesciences) in mitral position.At that time, the leaflets of the patient's native mitral valve were observed to be mild thickening without impeded mobility.At (b)(6), prolapse of annuluses were observed in both aortic and mitral position.Re-do avr and map were therefore performed.This valve was explanted and a 23 mm masters series mechanical heart valve (model number: 23aecj-502, serial unknown) was implanted instead.No detailed information regarding re-do map was provided.Subsequently the patient had been followed up at this hospital as an outpatient.At (b)(6), productive cough and fatigue on exertion became worse.An echocardiogram revealed the following findings: thickening of anterior leaflet of mitral valve (from the left atrial side just beneath aortic valve toward the anterior leaflet on mitral valve), mitral stenosis due to impeding leaflet mobility (peak velocity 2.3 m/s, pressure half time 170 m/s and tricuspid regurgitation pressure gradient (trpg) of 41.5 mmhg.As no thrombosis was shown on the mitral valve, either rheumatic lesion or tumorous lesion was suspected.Furthermore, as complete atrioventricular block (av block) was confirmed, mitral valve replacement (mvr) was performed after implantation of permanent pacemaker in ddd mode.A 27 mm masters series mechanical heart valve (model number: 27mecj-502, serial unknown) was sutured into place using everting mattress sutures.On the 3rd postoperative day, the patient was transferred from intensive care unit (icu) to an original ward.On the 30th postoperative day, the patient was discharged from the hospital.Reportedly, as granulomatous inflammation and necrotizing granulomas were confirmed on the leaflets of both the mitral and aortic valve, it was considered to be the lesion due to churg-strauss syndrome.Two months after mvr was performed, steroid pulse therapy for 3 days and gumma globlin therapy for 5 days were taken.Afterward, the patient has been visiting to this hospital and is being treated with administration of azathioprine and prednisolone.Lead author stated that churg-strauss syndrome is rare systemic vasculitis and heart complication such as pericarditis, myocardial infarction (mi) and pericardial effusion has poor prognosis.This case that simultaneously invited complications as valve disease and complete av block was also rare.However, regarding this kind of case, physicians are required to pay careful attention to monitoring and treatment strategy focusing the possibility of exacerbation or reoperative surgery.There is no information available regarding the serial number of this valve and replacement device, implant/explant date of this valve or the patient's current postoperative condition.Patient specific information of patient identifier, birthdate and weight are not available for this case.The patient is reported to be recovering.Any additional information is unexpected other than which is written in this literature.

• Brand Name: SJM REGENT HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7171725
• MDR Text Key: 96616858
• Report Number: 2648612-2018-00003
• 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: company representative,litera
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 21AGN-751
• Device Catalogue Number: 21AGN-751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/25/2017
• Initial Date FDA Received: 01/08/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 47 YR