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

Model Number 27AJ-501

Device Problem Perivalvular Leak (1457)

Patient Problems Congestive Heart Failure (1783); Prolapse (2475)

Event Type  Injury  

Manufacturer Narrative

An event of congestive "heart failure and pulmonary hypertension due to prolapse" and paravalvular leakage was 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.The valve had been implanted for over 23 years in a patient with a history of congenital mitral regurgitation.

Event Description

The following information was obtained from the professional literature of japanese society of pediatric cardiology and cardiac surgery (id# (b)(4)).The patient had congenital mitral regurgitation and aortic valve stenosis and mitral valvuloplasty was performed at the age of one year and six months.Mitral valve replacement was performed at (b)(6) and a 27 mm masters series mechanical heart valve was implanted.Concomitantly, aortic valve replacement was performed and a 23 mm artificial heart valve (unknown model) was implanted.After the procedure, the patient was reported to be stable.However, on the postoperative year 23 (at the age of (b)(6)), congestive heart failure and pulmonary hypertension due to prolapse of the mitral valve were observed.In addition, leakage was confirmed from perivalvular on the septal side.The valve was explanted and replaced with a 25 mm valve (unknown model).

• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8053107
• MDR Text Key: 126629855
• Report Number: 2648612-2018-00100
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 27AJ-501
• Device Catalogue Number: 27AJ-501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 36 YR