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

Model Number 21AGN-751

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/12/2022

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2022, a 21mm sjm regent heart valve was selected for procedure.It was noted during procedure that a leaflet of the regent valve became dislodged.The decision was made to remove and replace the 21mm sjm regent heart valve with a 17mm sjm regent heart valve to complete the procedure.There were no adverse patient consequences reported.

Manufacturer Narrative

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

Event Description

Subsequent to the previously filed report, additional information was received: it was reported that the leaflet of the 21mm sjm regent heart valve had dislodged when being positioned down into the patient's annulus.It was noted that the leaflet had dislodged as an entire piece.The dislodged leaflet is confirmed to have been removed from the patient.There was no noted difficulty or resistance rotating the valve.No instruments encountered the valve at the time of dislodgment and there was no attempt made to reinsert the dislodged leaflet.There was nothing else other than the holder handle used to position or rotate the valve.The 21mm sjm regent heart valve was noted as being in the fully closed position when being lowered into the patient's annulus.A correction needs to be made that a 19mm sjm regent heart valve was implanted as a replacement device, not a 17mm sjm regent heart valve as previously mentioned.It was noted that due to the unavailability of a another 21mm sjm regent heart valve, a 19mm sjm regent heart valve was selected as a replacement device.The 19mm sjm regent heart valve was deemed suitable for implant in the presence of another 21mm sjm regent heart valve.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.

Manufacturer Narrative

An event of leaflet dislodgment was reported.A returned device assessment could not be performed as the device was not returned for analysis.Information from the field indicated that no resistance was felt during the procedure.Field also indicated that no instruments encountered the valve at the time of dislodgment.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, the root cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.H6: health effect - clinical code: 4580 removed.Code 4582 added.H6: health effect - impact code: 4648 removed.Code 2199 added.

• Brand Name: REGENT HEART 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: 15581919
• MDR Text Key: 306897690
• Report Number: 2135147-2022-01592
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734005982
• UDI-Public: 05414734005982
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21AGN-751
• Device Catalogue Number: 21AGN-751
• Device Lot Number: 7119429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2019
• 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