MAUDE Adverse Event Report: ST. JUDE MEDICAL TRIFECTA; HEART-VALVE, MECHANICAL

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiogenic Shock (2262)

Event Type  Injury  

Event Description

Medtronic received information, that one day post implant the patient showed decline in their blood pressure.And as a result intravenous therapy (iv) began.Cardiogenic shock was suspected, due to tamponade.To rule out tamponade, the patient was brought into the operating room (or) for a re-thoracotomy.There was no overt bleeding or tamponade present.The patient then returned to the icu with iv inotropics and extracorporeal membrane oxygenation (ecmo).It was determined, that the cardiogenic shock was likely, due to stunning post cardiotomy.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TRIFECTA
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17525398
• MDR Text Key: 321064952
• Report Number: MW5132339
• Device Sequence Number: 1
• Product Code: LWQ
• 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: 05/31/2018

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