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

Model Number	21AGN-751
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022, a 22mm sjm regent heart valve was chosen for implant.During the procedure there was an attempt to rotate the device but there was resistance felt.Rotation was possible after sewing in the intra-annular position but was not possible after sewing in the supra-annular position.After suturing regent in the intra-annular position, the leaflet touched the subvalvular tissue and was removed due to poor opening.Therefore the leaflet was sutured in the supra-annular position to prevent contact with the subvalvular tissue.Since there was still a part that touched the subvalvular tissue, the device was rotated, but it did not turn at all, so force was applied and one leaflet came off as it is.The leaflet fell off as one intact piece and was recovered from the patient.There was an attempt to reinsert the dislodged leaflet but it was not successful.It was noted that the holder handle was fully inserted into the orifice at a 90 degree angle in accordance with the information for use.A non-abbott (18mm ap360 series) device was used to complete the procedure.There were no adverse patient effects.The patient is stable.There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
The reported event of a dislodged leaflet was confirmed.One leaflet was dislodged from the orifice and returned with the valve.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 that an attempt was made to rotate the valve even though resistance was felt, which could have contributed to the reported event.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Please note, per the instructions for use, "using the valve holder/rotator and the flexible valve holder handle model 905-hh, or the rigid valve holder handle model 905-rhh, rotate the valve in situ to the desired position.The valve should rotate freely.If resistance is noted, the valve holder/rotator may not be properly seated in the valve, the valve may not be in the fully closed position, or the valve may be oversized.If the valve does not rotate freely, do not force valve rotation."g1: manufacturing site updated to #3007113487.
Additional Manufacturer Narrative
Nah6: investigation code 4114 (device not returned) was removed.Code 3331 (analysis of production records) was added.

• 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): ABBOTT MEDICAL REG#3007113487; 177 county road b east; st. paul MN 55117 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15941871
• Report Number: 2135147-2022-02381
• Device Sequence Number: 6059540
• 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
• 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,Followup
• Report Date (Section B): 01/24/2023

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 Expiration Date: 02/15/2025
• Device Model Number: 21AGN-751
• Device Catalogue Number: 21AGN-751
• Device Lot Number: 7397066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2022
• Supplement Date Received by Manufacturer: 01/19/2023; 01/23/2023
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 01/23/2023; 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2020
• 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 Sex: Unknown