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

Catalog Number UNK REGENT HEART VALVE

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

An article from the japanese society of cardiovascular surgery; report a case of a 25mm sjm regent valve that was implanted by median sternotomy in a mitral position for the patient with mitral stenosis in 2000.After that, the leaflet became fixed in a closed position and mitral valve insufficiency was confirmed.Mics (minimally invasive cardiac surgery)-mvr was conducted in 2018.Neither congestion nor pulmonary effusion was observed prior to redo mvr.The redo was approached via the right fourth intercostal space thoracotomy.It was thickened intima became invaginated into the orifice ring and pannus proliferation was prominent.Fresh or organized thrombi was confirmed at the pivot guard and leaflet.The regent valve was explanted and a 25mm non-abbott device was implanted instead.Thrombi was also noted inside of left atrial appendage (laa) so closure of laa was concomitantly conducted.No complication was observed after the surgery.The patient was released from icu to the general ward on postoperative day 3 and discharged from the hospital on postoperative day 13.It's been 3 years from redo-mvr, the patient has been doing well.[the primary author and corresponding author of this article is murakami, takeshi , md ,15 yamatocho, sasebo city, nagasaki prefecture 857-1195 japan].

Manufacturer Narrative

As reported in a research article, a mechanical heart valve was explanted after 18 years of implant due to the leaflet becoming fixed and regurgitation.It was reported that pannus had proliferated on the valve and that thrombus was present on the leaflet and in the pivot recess.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or additional information was received for analysis.The pannus and thrombus reported could have contributed to the leaflet becoming fixed.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Date estimated the udi number is not known as the serial/lot number was not provided.

• 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: 15503447
• MDR Text Key: 300779258
• Report Number: 2135147-2022-01399
• 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: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK REGENT HEART VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 67 YR
• Patient Sex: Female