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 Obstruction of Flow (2423)

Patient Problem Thrombus (2101)

Event Type  Injury  

Manufacturer Narrative

An event of thrombus formation 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.

Event Description

The following event was obtained from, "the 54th annual meeting of japanese society of pediatric cardiology and cardiac surgery.Mentoring and raising in pediatric cardiology," (p58-01).At (b)(6) after birth, mitral valve replacement surgery (mvr) was performed and a 17 mm masters series mechanical heart valve was implanted due to acute mitral valve regurgitation from infantile idiopathic tendon rupture.After surgery, although the circulation dynamics were stable, thrombus formed on the valve at an early stage, and thrombolytic therapy was required.The patient is reported to be stable.

• 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: 8053099
• MDR Text Key: 126629332
• Report Number: 2648612-2018-00099
• 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: 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