MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM MASTERS SERIES MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Aortic Regurgitation (1716)

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.Investigation results will be provided in a subsequent submission.

Event Description

The article "early detachment of prosthetic aortic valve one year after replacement for severe aortic regurgitation due to perforated aortic valve aneurysm; a case of suspected hla-b52 positive behçet's disease" was reviewed.This research article is a case study on a (b)(6)-year-old male due to nocturnal paroxysmal dyspnea.The patient had a 19mm abbott mechanical valve implanted in the supra-annular position.One year post procedure, the valve was explanted due to mildly dilated sinus of valsalva and prosthetic aortic valve detachment from aortic annulus with moderate to severe pvl.There was no endocarditis found on the explanted valve, however it was suspected that the patient had behcet's disease, which may have caused the valve detachment.There is no allegation of malfunction of the abbott device.The article concluded that aortic valve aneurysm and its rupture are rare and most cases are caused by infective endocarditis.However, behçet's disease should be considered to ensure appropriate immunosuppressive therapy and modification.The primary author of the article is nobuhiko haruki, md of division of cardiology, (b)(6) hospital with the email (b)(6).

Manufacturer Narrative

Additional information: g4, h2, h3, h6 & h10.As reported in a research article, a mechanical valve detached from the annulus and was explanted.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined, however it was suspected that the patient had behcet's disease.

• Brand Name: SJM MASTERS SERIES MECHANICAL HEART VALVE
• 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
• MDR Report Key: 10601762
• MDR Text Key: 209129254
• Report Number: 2648612-2020-00099
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 61 YR