MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (CS-WOODRIDGE) SJM MECHANICAL HEART VALVE (UNKNOWN); HEART-VALVE, MECHANICAL

Model Number CVD0039

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Infarction, Cerebral (1771); Endocarditis (1834); Fever (1858)

Event Type  Injury  

Manufacturer Narrative

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

According to the article "a case of infective endocarditis without detection vegetations after aortic valve replacement" (p-394), a patient underwent aortic root and valve replacement and with a sjm mechanical valve (model/size unknown) secondary to aortic dissection.Two years post surgery, the patient presented to the hospital with repeated fever.Bacillemia was suspected and the patient was hospitalized with levofloxacin (lvfx) treatment.A blood culture test revealed (b)(6).Due to the patient's obese condition and postoperative aortic root replacement, tee and tte images were poor in quality and the presence of vegetation was not be able to be discerned on the aortic valve.Days later, cez and gm were required for diagnosis of ie (major criteria 1 and minor criteria 2 were applied).The patient presented with a cerebral bleed and was diagnosed as ie (major criteria 1 and minor criteria 3).The causal bacteria was (b)(6), however, the infective origin was not identified.Since the patient had just cerebral bleed, medication was tailored to the patient's risk.The patient had a persistent fever and cez+vcm+gm+rfp were administered in addition to rehabilitation which was also started.Two weeks post-hospitalization, a cerebellar infarct and splenic infarct occurred.Approximately 27 days post-hospitalization, gm and vcm were discontinued due to renal failure.Three weeks later, no enrichment bacteria was observed by fdg-pet/ct test.The patient was discharged a month later.The sjm valve remained implanted and no model/serial number was provided.

• Brand Name: SJM MECHANICAL HEART VALVE (UNKNOWN)
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); 177 east county road b; st. paul MN 55117
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5227032
• MDR Text Key: 31344975
• Report Number: 3007113487-2015-00047
• 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: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: CVD0039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2015
• 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): Required Intervention
• Patient Age: 22 YR