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

Model Number 17AGN-751

Device Problems Gradient Increase (1270); Obstruction of Flow (2423); Biocompatibility (2886)

Patient Problems Pleural Effusion (2010); Chest Tightness/Pressure (2463); Complete Heart Block (2627); Pericardial Effusion (3271)

Event Date 03/15/2020

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, high gradient, pericardial effusion, pleural effusion, and heart block occurred in a patient after a mechanical heart valve implant.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 "dual-chamber pacing for postoperative residual left ventricular gradient after aortic valve replacement and concomitant septal myectomy for severe aortic stenosis and subvalvular obstruction" was reviewed.This research article is a case study on a (b)(6)-year-old woman with a history of several episodes of unconsciousness was admitted because of exertional chest oppression.Electrocardiogram indicated normal sinus rhythm, left ventricular hypertrophy, severe aortic stenosis as well as pressure gradient within the left ventricular cavity.The patient underwent aortic valve replacement with a 17mm regent valve and concomitant septal myectomy.Postoperative echocardiography revealed significant residual mid ventricular pressure gradient.In addition, pericardial and pleural effusion was observed, for which pericardial drainage and left thoracic drainage were performed, along with intravenous administration of diuretics.The patient was also complicated by postoperative complete heart block, in which a dual-chamber pacemaker was implanted.During the last follow up, two years since the procedures, the patient was reported to be stable.There is no allegation of malfunction of the abbott device.The article concluded that dual-chamber pacing may have the potential to become one of the non-surgical therapeutic options for those with post-surgical residual subvalvular gradient, not only for severe aortic stenosis and subvalvular obstruction but also for obstructive hypertrophic cardiomyopathy.The primary author of the article is hikaru imafuku, md of department of medicine, chikamori hospital, kochi, japan.The correspondence author is yoshinori doi, md, with the corresponding email: ydoi@chikamori.Com.

• Brand Name: SJM REGENT 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 ; RQ 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725 ; RQ 00725
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10574233
• MDR Text Key: 208161613
• Report Number: 2648612-2020-00096
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 17AGN-751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2020
• 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; Other; Required Intervention
• Patient Age: 69 YR