MAUDE Adverse Event Report: SORIN SIZER, HEART-VALVE, PROSTHESIS

Model Number ART23SMT

Device Problem Insufficient Information (3190)

Patient Problem Myocardial Infarction (1969)

Event Type  Injury  

Event Description

Medtronic received information that two years and 8 months post implant of stentless bioprosthetic heart, patient was admitted for an apparent cerebrovascular accident.It was noted that the patient had elevated troponin levels and diagnosed with a myocardial infarction.Patient's heart rate was in the thirties and a permanent pacemaker was implanted during hospitalization.No additional adverse patient effects were reported.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SIZER, HEART-VALVE, PROSTHESIS
• Type of Device: SIZER, HEART-VALVE, PROSTHESIS
• Manufacturer (Section D): SORIN
• MDR Report Key: 17527849
• MDR Text Key: 321106027
• Report Number: MW5134780
• Device Sequence Number: 1
• Product Code: DTI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: ART23SMT
• Patient Sequence Number: 1