MAUDE Adverse Event Report: ABBOTT MEDICAL MASTERS SERIES EXPANDED HEMODYNAMIC PLUS VALVE; HEART-VALVE, MECHANICAL

Catalog Number 21MHPJ-505

Device Problems Perivalvular Leak (1457); Off-Label Use (1494)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/05/2024

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2024, a 21mm sjm masters series hemodynamic plus valve was chosen for implant in the tricuspid position.During procedure, the physician used an everything mattress technique with pledgets on the atrial side and oriented the valve in an anti-anatomical position.After suturing the valve, the physician checked for leaflet motion with a q tip and was satisfied.The bypass was turned off, but the echocardiogram showed an abnormal leak.The physician was very familiar with the jet's associated with our leaflet design, but this looked different to him.A decision was made to replace the valve and the physician turned on the bypass.A new 21mm sjm masters series hemodynamic plus valve was chosen and implanted using the same technique but they oriented the valve 45 degree's from the original orientation.The physician turned off the bypass and an echo was performed, no perivalvular leak (pvl) was noted.There was no reported consequences to the patient.

Manufacturer Narrative

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

Manufacturer Narrative

An event of perivalvular leak was reported.No anomalies were found with the valve leaflets, 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.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.It was reported that a 21 mm sjm masters series hp valve was chosen for implant in the tricuspid position.Please note that per instructions for use, "sjm¿ masters series mechanical heart valves are rotatable, bileaflet valves designed for implantation in the aortic or mitral position.".

Event Description

It was reported that on (b)(6) 2024, a 21mm sjm masters series hemodynamic plus valve was chosen for implant in the tricuspid position.During procedure, the physician used an everting mattress technique with pledgets on the atrial side and oriented the valve in an anti-anatomical position.After suturing the valve, the physician checked for leaflet motion with a q tip and was satisfied.The bypass was turned off, but the echocardiogram showed a moderate perivalvular leak (pvl).The physician was very familiar with the jet's associated with our leaflet design, but this looked different to him, the pattern of the jet design was not central but external in nature.A decision was made to replace the valve and the physician turned on the bypass.A new 21mm sjm masters series hemodynamic plus valve was chosen and implanted using the same technique but they oriented the valve 45 degree's from the original orientation.The physician turned off the bypass and an echo was performed, no perivalvular leak (pvl) was noted.There was no reported consequences to the patient.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.

• Brand Name: MASTERS SERIES EXPANDED HEMODYNAMIC PLUS VALVE
• 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: 18808985
• MDR Text Key: 336576490
• Report Number: 2135147-2024-00939
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05415067043733
• UDI-Public: (01)05415067043733(17)260802(10)8080454
• 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: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21MHPJ-505
• Device Lot Number: 8080454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2021
• 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
• Patient Age: 13 MO
• Patient Sex: Female