MAUDE Adverse Event Report: ST. JUDE MEDICAL SJM REGENT HEART VALVE W/FLEX CUFF; HEART-VALVE, MECHANICAL

Model Number 23AGFN-756

Device Problem Material Separation (1562)

Patient Problems Ventilator Dependent (2395); Cardiovascular Insufficiency (4445)

Event Date 01/13/2022

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

It was reported that on (b)(6) 2022, a 23mm sjm regent heart valve with flex cuff was chosen for implant.During procedure after the valve was sutured in, one prosthetic disc came out of the valve and fell into the ventricle during implantation.The intact leaflet was recovered from the patient and did not cause any damage to the ventricle or any other structures.The device was explanted and replaced with a 22mm non-abbott valve without any further complications.There was a clinically significant delay in procedure due to this event, and the patient required intra-aortic balloon pump (iabp) and high doses of inotropic medications to maintain hemodynamic parameters.Patient required a tracheostomy and was reported to still be recovering in the intensive care unit (icu) with the tracheostomy.No additional information was provided.

Manufacturer Narrative

An event of a dislodged leaflet was reported.Both the leaflets were intact to the valve.The orifice rim was chipped.No anomalies were found with the valve leaflets, and functional testing at the time of manufacturing and upon return to abbott indicated the valve functioned normally.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 reported event could not be conclusively determined.The cause of the reported event could not be conclusively determined.

• Brand Name: SJM REGENT HEART VALVE W/FLEX CUFF
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13515849
• MDR Text Key: 286741261
• Report Number: 3005334138-2022-00096
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006095
• UDI-Public: 05414734006095
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 23AGFN-756
• Device Catalogue Number: 23AGFN-756
• Device Lot Number: 8107921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 02/11/2022
• Supplement Dates Manufacturer Received: 04/14/2022
• Supplement Dates FDA Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2021
• 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; Hospitalization
• Patient Age: 57 YR