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

Model Number CVD0040

Device Problem Biocompatibility (2886)

Patient Problems Bradycardia (1751); Death (1802); Mitral Valve Stenosis (1965)

Event Type  Death  

Manufacturer Narrative

As reported in a research article, patient death occurred after a mechanical aortic valve replacement due to persisting low cardiac output.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 a research article identifying a 29mm mechanical mitral valve that may be related to death.The patient had a history of severe mitral valve stenosis and had previously underwent a mechanical aortic valve replacement.The 29mm mechanical mitral valve was then implanted.During reperfusion, bradycardia and impairment of lv contraction was observed and an intraaortic balloon was inserted with improvement to hemodynamic indicators and the patient was transferred to the icu.The patient passed away 48 hours later from persisting low cardiac output.Specific patient information is documented as unknown.Details are listed in the article, titled "situation awareness for circumflex artery injury during mitral valve surgery".

• Brand Name: SJM MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9376728
• MDR Text Key: 168032424
• Report Number: 2648612-2019-00093
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CVD0040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2019
• 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): Death
• Patient Age: 69 YR