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

Model Number 23MJ-501

Device Problem Obstruction of Flow (2423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/10/2018

Event Type  Injury  

Manufacturer Narrative

An event that "the valve was noted to be obstructed" was reported.The results of the investigation are inconclusive since the device remains implanted was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined. .

Event Description

On (b)(6) 2017, a 23 mm masters series mechanical heart valve was implanted.On (b)(6) 2018, the valve was noted to be obstructed.The patient is currently stable and undergoing thrombolytic therapy and will be followed up accordingly.No information on compliance with anti-coagulation therapy after 2017 surgery was made available.

Event Description

On (b)(6) 2017, a 23 mm masters series mechanical heart valve was implanted.Post-implant, the patient was reported to have been compliant with their anticoagulation therapy.On (b)(6) 2018, the patient presented with complaints of shortness of breath with no history of syncope.An echo performed upon admission noted mitral valve thrombus with peak gradient/mean gradient = 46/38 mmhg.The patient was transferred to the ccu from the emergency department for close observation and monitoring.She was started on management of heart failure.Fluoroscopy and 2d echo was done which showed the valve to be stuck.The patient was treated with streptokinase (stk) and after 24 hours of thrombolysis, one leaflet regained mobility but another was stuck with pg/mg = 20/13 mmhg.Stk was continued for another 24 hours.Fluoroscopy after 40 hours revealed normal mobility of the leaflet and pg/mg across mitral valve prosthesis decreased to 6/3 on 2d echo.The patient responded well to the treatment and recovered symptomatically.The hospital stay was uneventful and the patient was discharged on (b)(6) 2018.

• 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
• MDR Report Key: 7904474
• MDR Text Key: 121555340
• Report Number: 2648612-2018-00083
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006187
• UDI-Public: 05414734006187
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2021
• Device Model Number: 23MJ-501
• Device Catalogue Number: 23MJ-501
• Device Lot Number: 5776967
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR