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

Model Number CVD0039

Device Problems Microbial Contamination of Device (2303); Material Deformation (2976); Insufficient Information (3190)

Patient Problems Corneal Pannus (1447); Mitral Valve Stenosis (1965)

Event Date 09/15/2017

Event Type  Injury  

Event Description

On (b)(6) 1992, a mitral valve replacement (mvr) was performed and this 25mm sjm mechanical heart valve (mhv, details unknown) was implanted.Per report on (b)(6) 2017, a re-do mvr was performed due to mitral stenosis; the 25mm mhv was explanted and a 27mm on-x mechanical heart valve was implanted.Ex vivo, pannus ingrowth appeared to be present which the physician related to tissue-like pannus ingrowth rather than due to process of patient's growth.Per report, the patient was reported to be in stable condition.

Manufacturer Narrative

The device was returned due to mitral stenosis and pannus.Gross morphological and histopathological examination revealed one leaflet was dislodged from the orifice.It is unknown how or when this damage occurred.However, this damage is consistent with external force applied to the leaflet, which overstressed the carbon material and resulted in the damage.The second leaflet opened and closed completely and easily.There was essentially no pannus formation seen on remaining specimen.There was no inflammation or significant calcifications present on the valve.The cause of the reported event remains unknown.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 6954313
• MDR Text Key: 89477272
• Report Number: 2648612-2017-00087
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CVD0039
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention
• Patient Age: 30 YR