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

Model Number 21AGN-751

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 08/12/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2022 a 21mm regent mechanical heart valve was implanted successfully.On (b)(6) 2022, the valve was explanted due to lack of mobility of one of the valve leaflets that was confirmed on aortography.There was severe aortic insufficiency with circulatory collapse.A non-abbott device was successfully implanted.Patient was reported to be in stable condition at the time of report.

Manufacturer Narrative

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

Manufacturer Narrative

An event of leaflet immobility and aortic insufficiency with circulatory collapse 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.Based on the information received, the cause of the reported incident could not be conclusively determined.

Manufacturer Narrative

An event of leaflet immobility and aortic insufficiency with circulatory collapse 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.Based on the information received, the cause of the reported incident could not be conclusively determined.

Manufacturer Narrative

An event of leaflet immobility and aortic insufficiency with circulatory collapse was reported.The investigation at abbott found little tissue on the cuff of valve, but didn't impinge the leaflets.The orifice was chipped.No other damage was noted to the valve.Hydrodynamic testing upon return to abbott and at the time of manufacturing indicated the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.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 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.

• 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: 15420299
• MDR Text Key: 299888024
• Report Number: 2135147-2022-01199
• 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,Followup,Followup
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21AGN-751
• Device Catalogue Number: 21AGN-751
• Device Lot Number: 7732516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female