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

Model Number	23MJ-501
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/10/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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
• Common Device Name: 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
• Report Number: 2648612-2018-00083
• Device Sequence Number: 1438048
• Product Code: LWQ
• UDI-Device Identifier: 05414734006187
• UDI-Public: 05414734006187
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2018

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 10/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR