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

Model Number 27MJ-501

Device Problem Leak/Splash (1354)

Patient Problem Hemolytic Anemia (2279)

Event Type  Injury  

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 reported incident could not be conclusively determined.

Event Description

According to the article perivalvular leakage (pvl) after mitral valve replacement (mvr) was repaired by using the technique of threading needle from within coronary sinus (annual scientific meeting of the japanese association for thoracic surgery, 2016, vol.69, p.1001, pa-282), the following information was received: on an unknown date, an unspecified prosthetic valve was implanted in the aortic position.On an unknown date post-avr, a 27mm sjm mechanical heart valve was implanted in the mitral position.Post-implant, severe hemolytic anemia and leakage at the posteromedial commissure between 12 o¿clock and 4 o¿clock were observed.Due to projection of the aortic valve into the left ventricle, however, the visual field on the anterolateral commissure side of the mitral valve was limited.Also, the remaining tissue surrounding the annulus of mitral valve was insufficient and precluded a re-do mvr so 3-4 additional sutures with pledgets were placed to minimize the leak.No complications were reported.

• Brand Name: SJM MASTERS SERIES MECHANICAL HEART 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 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; 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: 6596372
• MDR Text Key: 76126638
• Report Number: 2648612-2017-00061
• 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: 05/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 27MJ-501
• Device Catalogue Number: 27MJ-501
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2017
• 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): Required Intervention