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

Model Number 27MJ-501

Device Problem Obstruction of Flow (2423)

Patient Problem Endocarditis (1834)

Event Date 09/09/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the serial number was unavailable.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

In 2001, the patient underwent mitral valve replacement due to active infectious endocarditis.A 27 mm sjm masters series mechanical valve (model: 27mj-501, serial: unknown) was implanted.On (b)(6) 2006, the 27 mm sjm masters series mechanical valve was explanted and replaced with a 25 mm sjm masters series mechanical valve (model: 25mj-501, serial: unknown) due to prosthetic valve endocarditis (pve) with staphylococcus lugdunensis.In (b)(6) 2015, the patient developed general malaise and was prescribed antibiotic therapy without impact on the symptoms.On (b)(6) 2015, the patient presented to the emergency room and staphylococcus lugdunensis was again confirmed by blood culture.Emergency hospitalization was required.On (b)(6) 2015, an mri confirmed subacute multiple cerebral infarction.On 07 september 2015, a transesophageal echocardiography (tee) confirmed vegetation on this 25 mm sjm masters series mechanical valve.On (b)(6) 2015, a re-do mitral valve replacement was performed.This 25 mm sjm masters series mechanical valve was explanted and replaced with another 25 mm sjm masters series mechanical valve (model: 25mj-501, serial: unknown).

• Brand Name: SJM MASTERS SERIES MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC. (CS); p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. (CS); p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5123785
• MDR Text Key: 27356928
• Report Number: 2648612-2015-00026
• 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
• Report Date: 09/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 27MJ-501
• Device Catalogue Number: 27MJ-501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2015
• 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: 79 YR
• Patient Weight: 48