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

Model Number 23AECJ-502

Device Problems Inadequacy of Device Shape and/or Size (1583); Difficult to Open or Close (2921)

Patient Problem No Code Available (3191)

Event Date 12/02/2014

Event Type  Injury  

Event Description

The 23 mm mechanical valve was explanted due to tissue growth which affected the full opening of one of the leaflets.The valve was replaced with a smaller 21 mm mechanical heart valve.

Manufacturer Narrative

The results of the investigation concluded mild limited mobility of one of the leaflets, and mild pannus formation with calcifications on the sewing cuff.There was no evidence found to suggest there was an intrinsic defect in the valve, as supported by the review of the device history record and by the analysis performed.The cause of the pannus formation, calcifications, and mild limited mobility of one of the leaflets remains unknown.

• Brand Name: MASTERS SERIES 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 0072 5
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 0072 5
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 4358770
• MDR Text Key: 5204345
• Report Number: 2648612-2014-00055
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2004
• Device Model Number: 23AECJ-502
• Device Catalogue Number: 23AECJ-502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/1999
• 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: 67 YR