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

Model Number 17AHPJ-505

Device Problem Missing Information (4053)

Patient Problems High Blood Pressure/ Hypertension (1908); Mitral Valve Stenosis (1965)

Event Type  Injury  

Manufacturer Narrative

Events of mitral stenosis, pulmonary hypertension, and left heart failure were reported.The results of the investigation are inconclusive since the device 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; however, the underlying congenital heart disease and associated patient conditions was a contributing factor.

Event Description

The following abstract information is from "the 54th annual meeting of japanese society of pediatric cardiology and cardiac surgery.Program: mentoring and raising in pediatric cardiology.(p58-01)".Five months after birth, an infant with congenital mitral stenosis and pulmonary hypertension underwent mitral valve replacement (mvr).A 17mm masters valve was implanted.Following surgery, mitral stenosis, pulmonary hypertension, left heart failure, cardiac asthma, , weight gain failure, and exercise limitation were observed from an early stage post-procedure.When the patient was (b)(6) old, redo mvr was performed and a 19mm sjm artificial heart valve was implanted.Remarkable stability was obtained postoperatively.

• 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
• 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: 8072251
• MDR Text Key: 127201735
• Report Number: 2648612-2018-00101
• 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: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 17AHPJ-505
• Device Catalogue Number: 17AHPJ-505
• 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: 3 YR