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

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Material Separation (1562)

Patient Problems Pulmonary Edema (2020); Tachycardia (2095); Cardiogenic Shock (2262); Foreign Body Embolism (4439)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, a 31mm st.Jude medical mitral valve prosthesis was implanted in a patient due to mitral stenosis.An event of atrial flutter, palpitations, hypotension, tachycardia, cardiogenic shock, pulmonary edema, supraventricular tachycardia, valve fracture, leaflet dislodgement, 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.

Event Description

The article, "escape of a leaflet from a st.Jude medical prosthesis in the mitral position", published in 1983 was reviewed.This research article presents a case study on a (b)(6) year old man who went into cardiogenic shock and pulmonary edema due to escape of one of the leaflets from the prosthesis.It was reported that a 31mm st.Jude medical mitral valve prosthesis was implanted in the patient at the age of 27 due to mitral stenosis.The device was successfully implanted and the postoperative course was uneventful.The patient had a short period of atrial flutter, but was discharged in sinus rhythm after digitalization.At 23 months post-operation, the patient experienced palpitations, hypotension and tachycardia and was found to be in cardiogenic shock and in severe pulmonary edema.Standard pulmonary edema treatment with digitalization, morphine and frusemide was instituted, but caused only slight improvement.The patient was then intubated and put on a respirator.The electroencephalogram (eeg) showed supraventricular tachycardia.Because of persistent cardiogenic shock and intractable pulmonary edema in spite of intensive treatment, it was decided to operate immediately without further investigation.At operation the st.Jude valve was nicely healed in with no perivalvular leak, but there was only one leaflet present in the prosthesis.This remaining leaflet was moving freely.The prosthesis was explanted.The left atrium, the pulmonary veins and the left ventricular cavity were examined with great care, but the escaped leaflet could not be found.An non-abbott mitral valve prosthesis size 29 was implanted.On inspection of the explanted valve a fracture was found in the valve housing going through one of the butterfly pivot areas corresponding to the escaped leaflet.Postoperatively, the patient needed inotropic and respiratory support for a prolonged period of time, but he subsequently recovered.The embolized leaflet was located in the abdominal aorta by 2d-echo and was retrieved 28 days after the emergency operation.The escaped leaflet was found to be macroscopically intact.The explanted prosthesis and the retrieved leaflet were examined optically and with scanning electron microscopy.The escape of the leaflet in this case was due to a fracture through the pivot area, however, the cause of the fracture was obscure.The article concluded that prosthetic malfunction not due to thrombosis or tissue interposition, although rare, can occur with the st.Jude medical heart valve prosthesis.It is extremely important to handle this all pyrolitic carbon valve prosthesis with great care before and during insertion.The primary and correspondence author of the article is e.Hjelms, m.D., department of cardiothoracic surgery , (b)(6).Blegdamsvej 9, dk·21 00 (b)(6).

• 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 ; * 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12199628
• MDR Text Key: 263607866
• Report Number: 2648612-2021-00077
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2021
• 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: 29 YR