MAUDE Adverse Event Report: ST. JUDE MEDICAL SJM MASTERS SERIES MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 27MJ-501

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

Patient Problems Death (1802); Heart Failure (2206)

Event Date 02/09/2012

Event Type  Death  

Event Description

A pt underwent mitral valve replacement using this 27mm sjm masters series valve.The pt experienced heart failure and expired on (b)(6) 2012.The physician did not believe death was due to the valve and no additional info is available.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each mfg and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the info received, the physician did not believe the death was valve related and the cause remains unk.

• Brand Name: SJM MASTERS SERIES MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL; caguas PR
• Manufacturer Contact: denise johnson, rn ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 3931257
• MDR Text Key: 4573231
• Report Number: 2648612-2014-00031
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2016
• Device Model Number: 27MJ-501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2011
• 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): Death; Hospitalization; Required Intervention
• Patient Age: 56 YR