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

Model Number 23AGFN-756

Device Problem Obstruction of Flow (2423)

Patient Problems Aortic Insufficiency (1715); Thrombus (2101)

Event Date 03/15/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, a 23mm regent mechanical heart valve was implanted in the aortic position.Approximately one week later, obstructed leaflets of the valve and aortic regurgitation were confirmed.Cardiac catheterization and thrombolysis was performed due to suspicion of thrombosis.Although some effects of thrombolysis were seen, surgical intervention was still required.On (b)(6) 2018, a 21mm regent mechanical heart valve (unknown serial) was used to exchange the original 23mm regent heart valve.The patient is reported to be in stable condition postoperatively.The surgeon believes that the original 23mm regent heart valve was not seated well and was larger than the annulus, resulting in paravalvular leakage.Furthermore, the physician believes thrombolysis helped treat obstruction of the leaflets.

Manufacturer Narrative

The reported event of obstructed leaflets and regurgitation could not be confirmed.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.Hydrodynamic testing at the time of manufacturing and upon return to abbott indicated the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.The cause of the reported event remains unknown.

• Brand Name: SJM REGENT HEART VALVE W/FLEX CUFF
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7385862
• MDR Text Key: 103968381
• Report Number: 2648612-2018-00020
• Device Sequence Number: 1
• Product Code: LWQ
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 23AGFN-756
• Device Catalogue Number: 23AGFN-756
• Device Lot Number: 6082965
• Other Device ID Number: 05414734006095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 16 YR
• Patient Weight: 53