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

Model Number SORIN PERCEVAL

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Tachycardia (2095)

Event Type  Injury  

Event Description

Medtronic received information that following the implant of a surgical aortic valve replacement, as the sternum was being closed, the patient went into a non-pulsatile ventricular tachycardia with no output.The chest was re-opened urgently, during this time external paddles were placed on the chest and direct-current (dc) reversion was performed to revert the patient back into a sinus rhythm.The pericardium was re-opened and the operative sites inspected.Intraoperative transoesophageal echocardiogram (toe) showed the valve was seated in the correct position with no regional wall abnormalities.Ventricular function was excellent after resuscitation.An extra suture was placed on the aortotomy suture line to address bleeding.As there was no sign of further bleeding/ooze the patient's chest was reclosed and they were transferred to the intensive care unit (icu) in stable condition.There no were no further arrhythmia's.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: PERCEVAL
• Type of Device: SIZER, HEART-VALVE, PROSTHESIS
• Manufacturer (Section D): SORIN
• MDR Report Key: 17519624
• MDR Text Key: 321051530
• Report Number: MW5126572
• 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: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: SORIN PERCEVAL
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1