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

Model Number	21AGN-751
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2023, a 21mm sjm regent heart valve was chosen for implant during an aortic valve replacement.Sizing was conducted using a sjm 905 sizer.The valve was attempted to be implanted, but the valve did not parachute well into the annulus using pledgets.The patient had a hypertrophied septum and heavy calcification on the annulus.The position of the sewing cuff was supra-annular.The physician believed that the valve was unable to parachute in well due to subvalvular tissue.The valve was removed and replaced with a 19mm sjm regent heart valve.The patient status was reported as stable.
Additional Manufacturer Narrative
An event of a valve not parachuting well into the annulus was reported.A returned device assessment could not be performed as 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.Information from the field indicated he patient had a hypertrophied septum and heavy calcification on the annulus which could have contributed to the reported event.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2023, a 21mm sjm regent heart valve was chosen for implant during an aortic valve replacement.Sizing was conducted using a sjm 905 sizer.A larger 21mm valve was chosen due to sizing concern.The valve was attempted to be implanted, but the valve did not parachute well into the annulus using pledgets.The patient had a hypertrophied septum and heavy calcification on the annulus.The position of the sewing cuff was supra-annular.The physician believed that the valve was unable to parachute in well due to subvalvular tissue.The valve was removed and replaced with a 19mm sjm regent heart valve.No adverse patient effects were reported.The patient status was reported as stable.

• Brand Name: REGENT HEART VALVE
• Common Device Name: 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: 16974219
• Report Number: 2135147-2023-02162
• Device Sequence Number: 2543498
• Product Code: LWQ
• UDI-Device Identifier: 05414734005982
• UDI-Public: 05414734005982
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 21AGN-751
• Device Catalogue Number: 21AGN-751
• Device Lot Number: 8377099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Female