MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM REGENT HEART VALVE W/FLEX CUFF; HEART-VALVE, MECHANICAL

Model Number 23AGFN-756

Device Problem Material Separation (1562)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)

Event Date 10/22/2019

Event Type  Injury  

Manufacturer Narrative

An event of a leaflet dislodgment during rotation and tamponade was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2019, a 23mm regent mechanical heart valve (mhv) was selected for a bentall procedure.While rotating the valve, a leaflet dislodged.The valve was removed and successfully replaced with another 23mm regent mhv.An hour postoperatively, the patient returned to the operating room (or) for ecmo placement.Then later was returned to the or for a tamponade.The patient is currently in the cardiac icu.

Event Description

On (b)(6) 2019, a 23mm regent mechanical heart valve (mhv) was selected for a bentall procedure.While rotating the valve, a leaflet dislodged.The valve was removed and successfully replaced with another 23mm regent mhv.An hour postoperatively, the patient returned to the operating room (or) for ecmo placement.Then later was returned to the operating room for a tamponade.The patient is currently in the cardiac icu.The user attributes the tamponade to the prolonged pump time with coagulopathy.

• Brand Name: SJM REGENT HEART VALVE W/FLEX CUFF
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 9336888
• MDR Text Key: 166836209
• Report Number: 2648612-2019-00098
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006095
• UDI-Public: 05414734006095
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2023
• Device Model Number: 23AGFN-756
• Device Catalogue Number: 23AGFN-756
• Device Lot Number: 6437487
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 122