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

Device Problem Insufficient Information (3190)

Patient Problems Atrial Fibrillation (1729); Heart Block (4444)

Event Type  Injury  

Event Description

Medtronic received information that one day following the implant of this sorin bioprosthetic valve, atrial fibrillation (afib) with left bundle branch block (lbbb) was noted.Nine days following the valve implant, complete heart block (chb) was noted.Eleven days following the valve implant, a permanent pacemaker was implanted.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: 17518316
• MDR Text Key: 321058026
• Report Number: MW5125264
• 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: 08/01/2018

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
• Patient Sequence Number: 1