MAUDE Adverse Event Report: SORIN HEART-VALVE, NON-ALLOGRAFT TISSUE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Tamponade (2226); Thrombocytopenia (4431)

Event Type  Injury  

Event Description

Medtronic received information that following the implant of a sorin surgical valve, thrombocytopenia was reported.The patient received one unit of platelets intraoperatively during surgical treatment of tamponade.The platelets continued to decrease and heparin was discontinued.Possible heparin induced thrombocytopenia was reported.No further 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: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): SORIN
• MDR Report Key: 17535855
• MDR Text Key: 321153250
• Report Number: MW5142748
• Device Sequence Number: 1
• Product Code: LWR
• 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: 11/10/2016

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