MAUDE Adverse Event Report: ST. JUDE MEDICAL SJM MASTERS SERIES VALVE EXPANDED CUFF; ROTATABLE HEART VALVE

Model Number 27MECJ-502

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Death (1802); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Rupture (2208)

Event Type  Death  

Event Description

According to a literature article, a sjm regent valve was implanted in the mitral position and a sjm masters series valve was implanted in the aortic position.Following the procedure, the patient was moved to the icu, where she was under sedation for 16 hours.At 17 hours after the sedation was discontinued, the patient's body motion and blood pressure increased.Heavy bleeding was found at the pericardium and the mediastinum drainage, and the patient went into cardiopulmonary arrest.Percutaneous cardiopulmonary support was performed.After a re-thoracotomy was performed the patient's left ventricle free wall ruptured.Due to the difficulty encountered when attempting to repair it and achieving hemostasis, the patient expired the following day."investigation for two cases of delayed-type left ventricle rupture after mitral valve replacement surgery." cardiovascular anesthesia, no.17, p.224, 2013.Reference medwatch report number 2648612-2014-00003.

Manufacturer Narrative

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 bleeding in the pericardium and the left ventricular wall rupturing remains unknown.

• Brand Name: SJM MASTERS SERIES VALVE EXPANDED CUFF
• Type of Device: ROTATABLE HEART VALVE
• Manufacturer (Section D): ST. JUDE MEDICAL; caguas PR
• Manufacturer Contact: denise johnson, rn ; 177 east county road b; st. paul, MN 55117 ; 6517564470
• MDR Report Key: 3631758
• MDR Text Key: 4177838
• Report Number: 2648612-2014-00004
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 27MECJ-502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 57