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

Model Number 15MHPJ-505

Device Problem Perivalvular Leak (1457)

Patient Problem Cardiac Tamponade (2226)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, a patient had reoperation due to retrocardiac bleed after valve implant.Paravalvular leak and explant of the valve was also reported.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.

Event Description

Reference manufacturing report: 2648612-2020-00016.It was reported through a research article identifying 15mm 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.

• 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 ; RQ 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725 ; RQ 00725
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9717208
• MDR Text Key: 189710323
• Report Number: 2648612-2020-00015
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 15MHPJ-505
• Device Catalogue Number: 15MHPJ-505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2020
• 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): Other; Required Intervention
• Patient Age: 5 MO