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

Model Number AGFN-756

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 05/26/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that on(b)(6)2023, a 21mm sjm regent heart valve with flex cuff was chosen for implant.The valve was not tested prior to implant.After the valve was implanted, the leaflets were tested with a rubber tube, and it was noted that the valve leaflet did not open and close well.The valve was removed and a new 19mm sjm regent heart valve with flex cuff was successfully implanted interprocedurally.The patient was reported as in stable condition.

Manufacturer Narrative

An event of the valve leaflets not opening and closing well was reported.Morphological and hydrodynamic examination indicated the valve met abbott specifications.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 regards to manufacture, design, or labeling.

Event Description

It was reported that on (b)(6) 2023, a 21mm sjm regent heart valve with flex cuff was chosen for implant.The diameter of the annulus was measured to be 21mm.The valve was not tested prior to implant.After the valve was implanted, the leaflets were tested with a rubber tube, and it was noted that the valve leaflet did not open and close well.The valve was removed and a new 19mm sjm regent heart valve with flex cuff was successfully implanted interprocedurally.A 19mm valve was chosen because the physician believed it would fit better in the patient.The patient was reported as in stable condition.

• 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: 17152507
• MDR Text Key: 317634938
• Report Number: 2135147-2023-02648
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734005975
• UDI-Public: 05414734005975
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AGFN-756
• Device Catalogue Number: 21AGFN-756
• Device Lot Number: C00004683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2022
• 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