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

Model Number 17MHPJ-505

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Mitral Insufficiency (1963)

Event Type  Injury  

Event Description

Reference manufacturing report: 2648612-2020-00015.It was reported through a research article identifying 17mm masters valve that may be related to surgical intervention post procedure.Details are listed in the article, titled "mitral valve replacement with the 15-mm mechanical valve: a 20-year multi-center experience." one of the patient was diagnosed with congenital mitral regurgitation and heart failure.The patient was intubated and on inotropic support immediately after birth.Due to the patient¿s poor cardiac condition, a15-mm mitral valve prosthesis at one day of age.The patient underwent a reoperation because of retrocardiac bleed causing tamponade.The patient was discharged home for 5 months and readmitted with a paravalvular leak.The prosthesis was replaced by a 17 mm mechanical valve.The patient received a second 25mm mechanical valve replacement 12.6 years after implantation of the 17-mm valve.The child remains well with the 25-mm valve at age 16 years with a mean gradient of 10.8 mm hg.Left ventricular function is good and there are no signs of pulmonary hypertension.

Manufacturer Narrative

As reported in a research article, a 17mm valve was replaced after 12.6 years with a 25mm mechanical valve.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SJM MASTERS SERIES HEMODYNAMIC PLUS 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: 9729270
• MDR Text Key: 189709406
• Report Number: 2648612-2020-00016
• 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,l
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

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 Model Number: 17MHPJ-505
• Device Catalogue Number: 17MHPJ-505
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/21/2020
• Initial Date FDA Received: 02/19/2020
• Supplement Dates Manufacturer Received: 03/02/2020
• Supplement Dates FDA Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 13 YR