MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM HEART VALVE (UNKNOWN)

Device Problems Entrapment of Device (1212); Incomplete Coaptation (2507)

Patient Problems Abscess (1690); Bacterial Infection (1735); Endocarditis (1834); Fatigue (1849); Unspecified Infection (1930); Test Result (2695)

Event Type  Injury  

Event Description

The information provided in a literature article titled, "case report of infective endocarditis associated with intracardiac shunt" indicated that in (b)(6) 2013, the (b)(6) year-old female patient presented with heart failure.She was diagnosed with an ascending aortic aneurysm and moderate aortic regurgitation.Emulgent was administered for the treatment then cardiac failure was resolved.In (b)(6) 2013, the ascending aortic replacement and aortic valve replacement (avr) were performed.This 19 mm sjm valve (model: unknown, serial: unknown) was implanted.Twenty-one days postoperatively, the patient was discharged from the hospital with favorable prognosis.In (b)(6) 2013, the patient presented with a chief complaint of fatigue.Blood tests revealed significant inflammation and infective endocarditis was suspected.The patient was readmitted to the hospital the same day.Three days later, an ultrasonic cardiogram revealed approximately 12 mm vegetation adherence on the tricuspid valve and blood cultures were positive for bacillus coli.On the 11th day after hospitalization, an ultrasonic cardiogram revealed poor seating of this aortic valve with motion and shunt flow from the valsalva sinus to the right atrium.On the 13th day after hospitalization, the patient underwent a bentall procedure, tricuspid valve replacement and valsalva sinus reconstruction.Intraoperatively, vegetation was observed to be adhered to the septal cusp of the tricuspid valve, and an abscess was observed on the annulus of the aortic valve and around the ascending aortic blood vessel prosthesis.Shunt flow towards the right atrium from a valsalva sinus of the commissure of the noncoronary cusp and the right coronary cusp was also confirmed.The 62nd annual scientific session of the japanese college of cardiology; literature id: 1410w4-23h.

Manufacturer Narrative

Gtin number: unknown since the model and serial number are unknown.

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.

• Brand Name: SJM HEART VALVE (UNKNOWN)
• Type of Device: SJM HEART VALVE (UNKNOWN)
• 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: 4280756
• MDR Text Key: 5227031
• Report Number: 2648612-2014-00052
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2014
• 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: 68 YR