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

Model Number 27MJ-501

Device Problem Sticking (1597)

Patient Problems Mitral Regurgitation (1964); Respiratory Distress (2045); Vomiting (2144)

Event Date 07/25/2014

Event Type  Injury  

Event Description

The info provided to sjm indicated the pt underwent a mitral valve replacement procedure with this valve due to severe mitral regurgitation.The pt presented to the hospital approximately 2 months postoperatively with vomiting and breathlessness.Echocardiography and fluoroscopy revealed the valve was stuck with tissue on the leaflets.Three doses of urokinase injections were administered.The valve was explanted and replaced with a 25 mm sjm epic tissue valve.Postoperatively, the pt was reported to be stable.

• Brand Name: SJM MASERS SERIES MECHANICAL HEART VALVE
• Type of Device: ROTATABLE HEART VALVE
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; caguas PR
• Manufacturer Contact: denise johnson, rn ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 4024492
• MDR Text Key: 16540175
• Report Number: 2648612-2014-00037
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• 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
• Report Date: 07/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2019
• Device Model Number: 27MJ-501
• Device Catalogue Number: 27MJ-501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2014
• Date Device Manufactured: 01/23/2014
• 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: 20 YR
• Patient Weight: 44