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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Pneumonia (2011); Renal Failure (2041); Pericardial Effusion (3271)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, 130 consecutive patients underwent robotic mitral valve replacement with sjm mechanical heart valves between 2014 and 2020.Events of arrhythmia, renal dysfunction, bleeding, infection, pneumonia, stroke, lymphoresis, neurological complications and pleural effusion were 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

Related manufacturing reference number: 2648612-2021-00026.The article, "comparison of postoperative outcomes between robotic mitral valve replacement and conventional mitral valve replacement" was reviewed.This research article is a retrospective single center experience to compare the postoperative results of robotic mitral valve replacement and conventional mitral valve replacement.Sjm mechanical heart valves were associated with the study.There is no allegation of malfunction of the abbott device.The article concluded that robotic mitral valve replacement is an effective and reliable method since total perfusion and cross-clamp times are longer, drainage amount and blood transfusion need are less, and ventilation time, intensive care, and hospital stay time are shorter.The primary and correspondence author of this article is huseyin sicim, md, department of cardiovascular surgery, university of health sciences, gulhanem training and research hospital, ankara, turkey with the corresponding email: drhuseyinsicim@gmail.Com.

• 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: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 11566145
• MDR Text Key: 242183720
• Report Number: 2648612-2021-00027
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2021
• 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): Hospitalization; Required Intervention