MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, B.V. (CD) SJM REGENT HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 25AGN-751

Device Problems Backflow (1064); Use of Device Problem (1670)

Patient Problem Aortic Regurgitation (1716)

Event Date 08/19/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.Investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2020 a double valve replacement and tv repair with laa ligation procedure was performed.The implanted 25agn-751 valve was found with transvalvular leakage under echo after procedure.No obstruction was observed during surgery.The 25agn-751 valve was explanted from the patient and replaced with 23agn.There was no transvalvular leakage found under echo.

Manufacturer Narrative

Additional information: d10, g4, h2, h3, h6 h10.The reported regurgitation could not be confirmed.No anomalies were found with the valve cusps, and functional testing at the time of manufacturing and upon return to abbott indicated the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported event could not be conclusively determined.

• Brand Name: SJM REGENT HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, B.V. (CD); lot 21; caguas west industrial park; caguas, puerto rico 00726 -099
• MDR Report Key: 10461609
• MDR Text Key: 204694859
• Report Number: 3003681312-2020-00011
• Device Sequence Number: 1
• Product Code: LWQ
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2022
• Device Model Number: 25AGN-751
• Device Lot Number: 6137652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention