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

Model Number 33MJ-501

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Endocarditis (1834); Mitral Regurgitation (1964); Pulmonary Edema (2020); Renal Failure (2041); Staphylococcus Aureus (2058); Septic Shock (2068); Multiple Organ Failure (3261)

Event Date 02/23/2015

Event Type  Injury  

Event Description

In (b)(6) 2014, the patient was diagnosed with infective endocarditis of the mitral valve thought to be caused by septic arthritis of the right knee.Antibiotics were prescribed.On (b)(6) 2014, this 33 mm sjm masters series mechanical heart valve was implanted during a mitral valve replacement.On (b)(6) 2015, the patient was diagnosed with staph aureus and infective prosthetic valve endocarditis.Mitral annular abcess with mitral valve dehiscence and severe mitral valve regurgitation were noted on transesophageal echocardiography.On (b)(6) 2015, the valve was explanted and replaced with a 27 mm sjm epic valve.Post procedure, the patient experienced acute pulmonary edema, renal failure, and underwent peritonial dialysis.On (b)(6) 2015, the patient expired due to septic shock and multi organ failure.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The results of this investigation concluded there was infectious endocarditis of the prosthetic valve, and the mechanical leaflets open and close completely.Special stains of the sewing cuff were positive for gram positive cocci and vegetations with acute inflammation.There was no evidence found to suggest the cause of the infectious endocarditis, microorganisms, and vegetations were due to an intrinsic defect in the valve, as supported by review of the valve's device history record and the analysis performed.The cause of the reported event remains unknown.

• 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 0072 5
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 0072 5
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 4621190
• MDR Text Key: 21560077
• Report Number: 2648612-2015-00007
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: 33MJ-501
• Device Catalogue Number: 33MJ-501
• Device Lot Number: 4678330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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): Death; Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 70