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

Model Number 27M-101

Device Problem Microbial Contamination of Device (2303)

Patient Problem Endocarditis (1834)

Event Type  Injury  

Manufacturer Narrative

An event of endocarditis 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; however, information from the field indicated a history of endocarditis prior to implant, and "(b)(6) was detected by blood culture," which is a known cause of endocarditis.

Event Description

The following information comes from the abstract of the "japanese journal of cardiovascular surgery" 2018, vol.47, no.4, p.166-169" titled: left ventricular pseudoaneurysm repair after mitral valve re-replacement for prosthetic valve endocarditis.Approximately 14 years ago (date unknown), mitral valve replacement (mvr) was performed for the treatment of infective endocarditis (ie).Intraoperatively, vegetations adhered toward the posteromedial commissure separately from the center of the anterior leaflet and the posterior leaflet on the patient's native mitral valve.Therefore, the anterior leaflet was completely removed.Almost all the posterior leaflet was incised but the area attached to basal chorda was only preserved.Subsequently, this 27mm mechanical heart valve (model number: 27m-101, serial unknown) was implanted in the mitral position.The postoperative course had been uneventful with no findings of infection.On an unknown date, the patient presented to the hospital due to dysarthria and headache.A magnetic resonance imaging of the brain was performed and multiple cerebral infarction was shown.The patient was admitted to this hospital.As the patient had a fever, blood culture was conducted and antibiotic therapy started with ceftriaxone.In order to determine the factor of fever, a transesophageal echocardiography (tee) was performed.It revealed that a 7x7 mm vegetation adhered to this mechanical heart valve.Furthermore, (b)(6) was detected by blood culture.The patient was diagnosed as prosthetic valve endocarditis (pve) associated with cerebral septic embolization.The antibiotic was changed to cefazolin, gentamicin and rifampicin; however, the vegetation was mobile and there was a high risk of further embolization.On day 8 of hospitalization, re-do mvr was performed and this valve was explanted.A 27mm epic valve (model number: e100-27m, serial unknown) was implanted as the replacement.When attempting to remove the patient from the cardiopulmonary bypass after releasing of aortic cross clamping, active bleeding was observed from the posterior wall of left ventricle which ruptured proximal to the groove between the atrium and the ventricle.The replacement epic valve was immediately explanted from the patient and the ruptured site was repaired with bovine pericardial patch.Due to suturing of the ruptured left ventricle, the diameter of the mitral annulus became slightly smaller.In order to avoid contacting the stent post of tissue valve with the rupture site, a 25mm mechanical heart valve (model number: 25m-101, serial unknown) was selected for use.The 25mm mechanical heart valve was successfully implanted in the patient and the procedure was completed without any further issues.The patient's general condition was reported to be stable postoperatively.On the 7th postoperative day, a 23mm pseudoaneurysm was confirmed on the posterior wall of the left ventricle through a computed tomography.On the 23rd postoperative day, the diameter of the pseudoaneurysm was measured 40mm.On the 74th postoperative day, the pseudoaneurysm had enlarged to 42mm and seemed to keep growing.On the 112nd postoperative day, the patient¿s rehabilitation after cerebral infarction was successful and the function of her extremities improved.A reoperative surgery for the pseudoaneurysm repair was performed.The orifice of the pseudoaneurysm was initially closed using bovine pericardium.After approximately 4 months, fibrotic tissue was formed around the orifice area and made it easier for suturing.The tissue adhesive (beriplast p combi-set tissue adhesion) were used to embolize the inside of pseudoaneurysm.The pseudoaneurysm wall was stitched up and trimmed at the end.The patient was recovering and making good progress.At 14 days after the reoperative surgery, no residual pseudoaneurysm was shown via a contrast enhanced ct.The configuration of the left ventricle was normal.At 29 days after the reoperative surgery, the patient was discharged from the hospital on foot.The recurrence of pseudoaneurysm was not confirmed approximately one year after the reoperative surgery.The replacement 25mm mechanical heart valve remains implanted in the patient.The risk factor that left ventricular posterior wall is ruptured after mvr has been reported in the following cases: advanced age, female and the patient underwent re-do surgery.It is considered that rupture of pseudoaneurysm like this reported case relate strongly to the disruption of the myocardium.Although there was concern of enlargement or rupture of the pseudoaneurysm, the surgeon waited to conduct the reoperative surgery at the patient¿s request where she hoped to preferentially continue the rehabilitation instead of surgery.As a result, the fibrotic tissue was formed at the orifice area, then it led to reduce the risk of the aneurysm rupture and to conduct the safe and sure surgery.This case may be one of remedy for the rupture of left ventricular posterior wall with the type of pseudoaneurysm.Any additional information is unexpected other than which is written in this literature.

• Brand Name: SJM MECHANICAL 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7852729
• MDR Text Key: 119487459
• Report Number: 2648612-2018-00070
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 27M-101
• Device Catalogue Number: 27M-101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/15/2018
• 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: 69 YR