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

Model Number CVD0039

Device Problems Obstruction of Flow (2423); Incomplete Coaptation (2507); Biocompatibility (2886)

Patient Problems Hemoptysis (1887); Mitral Valve Stenosis (1965); Thrombus (2101)

Event Date 10/08/2018

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, a patient had stenosis, increased gradient, and an immobile leaflet due to a thrombus which resolved after treatment.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported through an article (titled - case report of successful low-dose, ultra-slow infusion thrombolysis of prosthetic mitral valve thrombosis in a high risk patient after redo-mitral valve replacement) that a patient underwent a mitral valve replacement with a 25mm mechanical prosthesis because of recurrent moderate to severe mitral regurgitation after mitral valve repair in the same year due to symptomatic severe primary mitral regurgitation of (post-) inflammatory etiology.Seven (7) months post implant, the patient presented to the emergency department with dyspnea, chest pain, and hemoptysis.Imaging revealed increased gradient with impaired movement of one of the prosthesis discs, severe stenosis, a prosthetic valve thrombosis.A therapy with diuretics and iv unfractionated heparin was initiated.The thrombus and disc motion were resolved on the next day, with pressure gradient returning to the baseline value.The patient was reported to be stable at discharge.

• Brand Name: SJM MECHANICAL HEART VALVE (UNKNOWN)
• 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: 9901353
• MDR Text Key: 187714011
• Report Number: 2648612-2020-00042
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CVD0039
• Device Catalogue Number: CVD0039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2020
• 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; Life Threatening; Other; Required Intervention
• Patient Age: 52 YR