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

Device Problem Obstruction of Flow (2423)

Patient Problems Hypoxia (1918); Thrombosis (2100); Valvular Stenosis (2697)

Event Type  Injury  

Manufacturer Narrative

(b)(4) the results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the serial number was unavailable.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The following information was obtained from a literature article titled " a case of thrombosis occurred in a patient taking novel oral anticoagulants (noac)" from the japanese journal of artificial organs, vol.44 no.2.2015.A late 50s male underwent mitral valve replacement and maze operation 15 years ago for the treatment of mitral stenosis and spasmodic atrial fibrillation.This 27 mm sjm mechanical valve was implanted as well as a pacemaker (ddd).The patient was taking warfarin but recently (unknown date), he switched from warfarin to dabigatran.Three months ago, the patient presented with congestive heart failure and was hospitalized twice in local hospital and diuretics were administered.Five days later, the patient's respiratory status deteriorated and non-invasive positive-pressure ventilation (nppv) was started.An echocardiogram confirmed mitral stenosis and the patient was referred to the hospital by ambulance with intubation.The patient had shock symptoms and cerebral hypoxia (fio2 100%, po2 89mmhg).This 27 mm sjm mechanical valve had leaflet immobility and the left ventricular chamber had shrunk.Moderate tricuspid regurgitation was also observed.An emergency re-do mitral valve replacement was performed due to severe thrombosis.This 27 mm sjm mechanical valve was explanted and replaced with a 27 mm ats mechanical valve.Tap (kay-reed) was also performed.After the surgery, brain ct confirmed cerebral hypoxia.The patient underwent percutaneous endoscopic gastrostomy (peg) and he was transferred to another hospital in a vegetative state.

• Brand Name: SJM MECHANICAL HEART VALVE (UNKNOWN)
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC. (CS); p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. (CS); p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5273230
• MDR Text Key: 32878906
• Report Number: 2648612-2015-00036
• 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: 12/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2015
• 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; Disability