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

Model Number 19AGFN-756

Device Problems Insufficient Information (3190); Physical Resistance/Sticking (4012)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/02/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

I was reported a 19mm sjm regent heart valve w/flex cuff was chosen for procedure.During the procedure, after the device had been implanted, the patient developed aortic root bleeding and the user reported there were problems with the valve.The user decided to exchange the valve for a new.No additional information has been provided.

Event Description

It was reported a 19mm sjm regent heart valve w/flex cuff was chosen for procedure.During the procedure, after the device had been implanted, the patient developed bleeding from the aortic root.The patients reported blood loss was 130ml and the cause was reported to be related to the patients high blood pressure and the patients history of a blood disease.The user chose the 19mm sjm regent heart valve w/flex cuff and discovered that there was a problem with the valve ability to open and close.The user exchanged the device but because the aorta was "reinforced" it was felt a smaller 17mm sjm regent heart valve w/flex cuff would be a better suited for the patient.The patient did remain stable during the procedure, however, the event did cause the patient to have an extended time on cardiopulmonary bypass and two days in the intensive care unit (icu).The patient has since been discharged.

Manufacturer Narrative

An event of a problem with the valve's ability to open and close was reported.Morphological and hydrodynamic examination indicated the valve met abbott specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Hydrodynamic testing upon return to abbott and at the time of manufacturing indicated the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.The cause of the reported event could not be conclusively determined.

• Brand Name: SJM REGENT HEART VALVE W/FLEX CUFF
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13055664
• MDR Text Key: 282607500
• Report Number: 3007113487-2021-00112
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734005852
• UDI-Public: 05414734005852
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 19AGFN-756
• Device Catalogue Number: 19AGFN-756
• Device Lot Number: 7607718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention