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

Model Number 33MJ-501

Device Problems Gradient Increase (1270); Material Too Rigid or Stiff (1544)

Patient Problem Mitral Insufficiency (1963)

Event Date 01/30/2018

Event Type  Injury  

Event Description

On an unknown date, a 33mm sjm masters series valve was implanted.On (b)(6) the valve was explanted due to a high pressure gradient in the presence of restricted leaflet mobility.Another valve was implanted (unknown model/serial number).The patient has been discharged from the hospital.

Manufacturer Narrative

An event of a high pressure gradient and restricted leaflet mobility was reported.The returned 33mm masters series valve met abbott specifications.There was no evidence found to suggest the reported event was due to an intrinsic defect in the valve, as supported by review of the valve's device history record.Functional testing at the time of manufacturing and hydrodynamic testing upon return to abbott indicated the valve functioned normally.These tests ensure proper leaflet coaptation and hemodynamic performance.The cause of the reported event remains unknown.

• 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 ; 6517565400
• MDR Report Key: 7295445
• MDR Text Key: 100887990
• Report Number: 2648612-2018-00016
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2019
• Device Model Number: 33MJ-501
• Device Catalogue Number: 33MJ-501
• Device Lot Number: 4833810
• Other Device ID Number: 15094661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2018
• Initial Date FDA Received: 02/25/2018
• Supplement Dates Manufacturer Received: 03/27/2018
• Supplement Dates FDA Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2014
• 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