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

Device Problems Migration or Expulsion of Device (1395); Material Separation (1562)

Patient Problems Pulmonary Embolism (1498); Dyspnea (1816); Hemoptysis (1887); Tachycardia (2095); Foreign Body Embolism (4439); Heart Failure/Congestive Heart Failure (4446)

Event Date 09/09/1983

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, "spontaneous ernbolization of a st.Jude prosthetic mitral valve leaflet", published in 1984 was reviewed.This research article presents a case study on a (b)(6)-year-old boy who experienced left ventricular failure due to leaflet embolization.On (b)(6) 1982, a 27mm st.Jude medical mechanical valve was implanted in the patient who had a history of endocarditis and rheumatic mitral valve.The patient's recovery was uncomplicated, and the patient was discharged from the hospital on the twelfth postoperative day.On (b)(6) 1983, 20 months after valve replacement, the patient awoke feeling more tired than usual.The patient attempted to walk to school but became severely dyspneic and experienced central chest pain with a rapid heartbeat.On arrival to the hospital the patient was coughing up blood and was experiencing tachycardia.The patient was diagnosed with pulmonary embolism and was given heparin and oxygen, but the patient's hemodynamic status slowly deteriorated, with system hypotension, oliguria and restlessness.Cinefluoroscopy was done and only one leaflet was seen.Emergency valve replacement was undertaken 60 hours after the onset of symptoms.The mitral valve leaflet in the superior position was missing.The valve was excised and the inside of the heart and the aortic root were carefully palpated for the missing leaflet, which was not found.The valve was replaced with a 27mm non-abbott valve.On the sixth postoperative day, fluoroscopy showed the mobile embolized leaflet at the bifurcation of the abdominal aorta, and ten days after valve replacement the intact, grossly normal leaflet was removed.The remainder of the postoperative course was uneventful.The explanted valve with one intact leaflet and the recovered embolized leaflet were examined by st.Jude medical.Cracks were observed near the four butterflies on both sides of the pivot guards.The upper wall edges of two of the butterflies were chipped the recovered embolized leaflet was intact and dimensionally within specifications.The article concluded that acute cardiac symptoms in a patient with a prosthetic cardiac valve demand careful assessment of the function of that valve.Because of the unique bileaflet design of the st.Jude prosthetic heart valve, symptoms and signs of malfunction may be more subtle than with other prosthetic valves, and a high index of suspicion is required.The primary and correspondence author of the article is j.A.Odell, md, wentworth hospital, jacobs, durban, south africa.

Manufacturer Narrative

Additional information for:g3, g6, h2, h6, and h10.As reported in a research article, a leaflet embolized from a mechanical heart valve 20 months after valve implant.Also reported was that cracks were observed near the butterfly recessed areas and that the force required to dislodge the leaflet was less than one-third the force required to dislodge a leaflet from an undamaged valve, suggesting the leaflet dislodged after the orifice was fractured.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: 12233193
• MDR Text Key: 264276977
• Report Number: 2648612-2021-00080
• 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: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR