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

Model Number CVD0040

Device Problem Insufficient Information (3190)

Patient Problems Aneurysm (1708); Infarction, Cerebral (1771); Fever (1858); Unspecified Infection (1930); Mitral Regurgitation (1964); Paralysis (1997); Cancer (3262)

Event Type  Injury  

Manufacturer Narrative

Gtin: unknown as no device identifiers were present.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 journal article "resection of infected aneurysm at the left colic artery after mitral valve replacement for infective endocarditis" (j microbial immunol infect 2009; 42: 154-159), a patient implanted with a 29mm sjm mechanical valve suffered from hemiplegia and high fever.A cerebral mri confirmed an acute cerebral infarction and echo revealed mitral regurgitation with floating vegetations attached to both anterior and posterior mitral leaflets.An urgent mitral valve redo procedure was performed.The patient had no dental treatment history.Ex vivo, a blood culture did not grow any bacteria.Appetite loss and low grade fever continued post-mitral valve replacement and a cat identified a 5x3cm infected aneurysm at the left colic artery and colon cancer.The patient underwent resection of the infected arterial aneurysm and simultaneous ileocecal resection.Post-operative course was uneventful.

• Brand Name: SJM® MECHANICAL HEART VALVE
• 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: 5159619
• MDR Text Key: 28616995
• Report Number: 3007113487-2015-00036
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CVD0040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2015
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR