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

Catalog Number	19AGFN-756
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
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 04 january 2024, a 19mm regent aortic mechanical heart valve (mhv) was chosen for implant.The patient was presented with rheumatic heart disease (rhd).During implantation, one leaflet got dislodged from pivot and fell into the left ventricle cavity.The holder handle was fully inserted into the orifice at a 90 degree angle, and this event was not during rotation of the valve.The intact leaflet was recovered from the patient.The device was removed and discarded.A replacement 17mm regent aortic mechanical heart valve (mhv) was successfully implanted.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported to be stable.
Additional Manufacturer Narrative
An event of the detachment of device or device component with leaflet dislodgement was reported.The investigation found that one leaflet was dislodged.The other leaflet was intact in the orifice and was mobile.The orifices were undamaged.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 during implantation, one leaflet got dislodged from pivot and fell into the left ventricle cavity.The intact leaflet was recovered from the patient.The device was removed and discarded.The holder handle was fully inserted into the orifice at a 90 degree angle.A new replacement regent aortic mechanical heart valve (mhv) was successfully implanted.Based on the information reviewed, the root cause of the leaflet dislodgement could not be conclusively determined.Here is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: REGENT HEART VALVE WITH FLEX CUFF
• 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: 18592070
• Report Number: 2135147-2024-00383
• Device Sequence Number: 12476968
• Product Code: LWQ
• UDI-Device Identifier: 05414734005852
• UDI-Public: (01)05414734005852(17)280412(10)C00010973
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 04/15/2024

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 Catalogue Number: 19AGFN-756
• Device Lot Number: C00010973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/04/2024
• Supplement Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2023
• 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