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 Edema (2020); Cardiogenic Shock (2262); Foreign Body Embolism (4439); 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, "emergency valve re-replacement for embolization of prosthetic mitral valve disc during catheterization procedure", was reviewed.This research article presents a case study on a (b)(6) women with rheumatic heart disease, who underwent tissue mitral valve replacement remotely, which was replaced with a mechanical prosthesis in 1996 due to structural valve deterioration.In 2002, the patient had an emergency valve re-replacement with a st.Jude bi-leaflet mechanical valve for acute valve thrombosis during pregnancy.The patient recently experienced symptomatic paroxysmal atrial fibrillation, for which the patient underwent catheter ablation.During the procedure the patient experienced acute severe mitral regurgitation.This was visualized on fluoroscopy as coinciding with the dislodgment of one of the mechanical valve leaflets, which embolized to the descending thoracic aorta.The patient immediately exhibited pulmonary edema and cardiogenic shock and was supported with a left ventricular assist device.The patient was transferred to the operating room to undergo emergency surgery.The patient underwent re-operative sternotomy and became hemodynamically unstable with acute right ventricular failure after the repeat sternotomy.Cardiopulmonary bypass was initiated.Under cold cardioplegic arrest, the mechanical mitral valve was exposed through the interatrial groove.One of the leaflets of the valve was confirmed to be missing, but the remainder of the prosthesis was intact.The damaged prosthesis was replaced with a 27mm non-abbott mechanical valve.The patient was extubated the following day and transferred to the ward on the third postoperative day.Computed tomographic angiography on day 3 located the missing disc in the abdominal aorta.On postoperative day 6 the patient underwent a laparotomy with the distal abdominal aorta exposed through a retroperitoneal approach and the leaflet was extracted.The patient was discharged home uneventfully one week after the abdominal surgery.The patient remained well, asymptomatic, and in sinus rhythm a year after the procedure.The article concluded that with a growing cohort of patients with mechanical mitral prostheses and expanding utilization of percutaneous interventions for atrial arrhythmias and also for transcatheter valve replacement and treatment of paravalvular leaks, surgeons and interventional cardiologists should be familiar with the potential for this complication and its management.The primary author of the article is amit pawale, md, department of cardiothoracic surgery, and division of vascular surgery, department of surgery, mount sinai medical center, new york, new york.The correspondence author of the article is anelechi c.Anyanwu, md, department of cardiothoracic surgery, mount sinai medical center, 1190 fifth ave, gp 2w, box 1028, new york, ny 10029 with the corresponding email: anelechi.Anyanwu@mountsinai.Org.

Manufacturer Narrative

As reported in a research article, a patient had an emergency valve replacement due to thrombosis and one of the valve leaflets embolizing during a catheter ablation procedure.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: 12217425
• MDR Text Key: 263134271
• Report Number: 2648612-2021-00079
• 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: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 07/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• 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: 47 YR