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

Device Problem Backflow (1064)

Patient Problems Fatigue (1849); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

The article, "clinical outcomes of mitral valve replacement with the commercially smallest mechanical valve in neonates and infants" was reviewed.This research article presents a case study on a (b)(6) year old patient who underwent explant of a previously implanted sjm mechanical heart valve.It was reported that the patient had a 16mm sjm mechanical valve implanted in a mitral supra-annular position.After the surgery, warfarin and aspirin (asa) were prescribed and the patient's international normalized ratio(inr) was being controlled within 2 to 3.4.6 years post-procedure, the patient underwent a re-do surgery due to mitral regurgitation(mr) and easy fatigability.Mitral valve inflow was 2.7m/s and the tricuspid pressure gradient(trpg) was 36mmhg at rest and 62mmhg at exertion.The sjm mechanical valve was explanted and a 22mm non-abbott valve was implanted instead.The patient tolerated the redo surgery well and recovered uneventfully.No further information is available.

Manufacturer Narrative

As reported in a research article, a 16mm sjm mechanical valve was implanted in a mitral supra-annular position.Six years post procedure an event of mitral regurgitation, fatigue, tricuspid gradient, and valve explant was reported.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.

• Brand Name: SJM 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: 12005349
• MDR Text Key: 256441957
• Report Number: 2648612-2021-00069
• 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
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• 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: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR
• Patient Weight: 15