MAUDE Adverse Event Report: ABBOTT MEDICAL REGENT HEART VALVE WITH FLEX CUFF; HEART-VALVE, MECHANICAL

Model Number AGFN-756

Device Problem Incomplete Coaptation (2507)

Patient Problem Insufficient Information (4580)

Event Date 05/03/2022

Event Type  Death  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported a 23mm regent mechanical heart valve (mhv) was chosen for implant on (b)(6) 2022.The 23mm regent valve was placed but it was noticed that one of the leaflets was not moving properly.It was decided to rotate the valve but it was not possible.During the attempt to rotate a leaflet had dislodged into the patient's ventricle.The leaflet was retrieved and the valve was removed.A 21mm regent mhv was placed.The patient was removed off the cardiopulmonary bypass (cpb).At this point it was observed that the leaflets were not moving properly.The patient was placed on cpb and an attempt to rotate the valve was unsuccessful.The 21mm regent mhv was explanted and a non-abbott tissue valve was placed.The procedure was prolonged, the extra time in the operating room and having to restart the patient on cpb impacted the patient.The patient did not recover and passed away.The day of death is unknown.

Manufacturer Narrative

An event of leaflets not moving properly was reported.Morphological and hydrodynamic examination indicated the valve met abbott specifications.The valve was able to rotate without difficulty.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.Hydrodynamic 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 cause of the reported event could not be conclusively determined.

Event Description

It was reported a patient who had shortness of breath, palpitations and chest pain underwent a valve implant procedure on (b)(6) 2022.It was noted that the patient was clinically stable prior to the procedure.A 23mm regent mhv was chosen for implant.The valve was sized and the annulus measurement of the first valve at 2.54 prior to the implant.The first valve, a 23mm regent valve was placed and in a closed position but was unable to rotate the valve.During the attempt to rotate, a leaflet had dislodged and dropped into the patient's ventricle.The leaflet was retrieved and the valve was explanted.A smaller, 21mm regent mhv was placed and after placing the patient removed off the cardiopulmonary bypass (cpb).It was at this time the physician observed the leaflets were not moving properly.The patient was placed back on cpb and an attempt to rotate the valve was unsuccessful.The 21mm regent mhv was explanted and a non-abbott thv was placed.The procedure was prolonged, the extra time in the operating room and having to restart the patient on bypass impacted the patient.The patient did not recover and has passed away on 4 may, 2022 of reported heart disease.

• Brand Name: REGENT HEART VALVE WITH FLEX CUFF
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14671714
• MDR Text Key: 293821297
• Report Number: 2135147-2022-00371
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734005975
• UDI-Public: 05414734005975
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AGFN-756
• Device Catalogue Number: 21AGFN-756
• Device Lot Number: 7699276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2020
• 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
• Treatment: REGENT AORTIC MHV, 23AGFN-756, 18523607.
• Patient Outcome(s): Death
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 68 KG