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

Catalog Number 17AGFN-756

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Obstruction/Occlusion (2422)

Event Date 02/20/2024

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) 2024.A 17mm sjm regent heart valve w/ flex cuff was chosen for a aortic valve replacement (avr).The annular dimension of the native valve was approximately 17¿~19¿ by echocardiography.During procedure, the device did not fall into the annulus and blocked the right coronary artery (rca).There was a strong resistance noted while parachuting the valve into the annulus.The device was removed interprocedurally.An annulus dilation was performed.A new 19mm non-abbott valve was implanted.A prolonged procedure time required.The patient was reported stable.

Manufacturer Narrative

An event of device did not fall into the annulus and blocked the right coronary artery was reported.It was also reported that the resistance when parachuting the valve into the annulus.Additionally valve was explanted and a replacement non-abbott valve was used to complete the procedure.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was also 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.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 18918960
• MDR Text Key: 337844335
• Report Number: 2135147-2024-01171
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734005791
• UDI-Public: (01)05414734005791(17)281003(10)C00015987
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 17AGFN-756
• Device Lot Number: C00015987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/05/2023
• 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