MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. 21MM AORTIC EXPD CUFF MA STERS; HEART-VALVE, MECHANICAL

Model Number 21AECJ-502

Device Problems Gradient Increase (1270); Perivalvular Leak (1457)

Patient Problem Aortic Insufficiency (1715)

Event Date 04/13/2017

Event Type  Injury  

Event Description

A 21 mm sjm masters series mechanical heart valve was implanted on (b)(6) 1999.On (b)(6)2017, a paravalvular leak and a high gradient were noted.The valve was explanted and replaced with a magna ease valve.The patient is well and recovering from surgery.

Manufacturer Narrative

The results of this investigation concluded there was inflow pannus, which possibly obstructed full closure of one mechanical leaflet.No inflammation was present in the valve.A review of the device history record showed the device met specifications prior to leaving abbott manufacturing facilities.There was no evidence found to suggest the cause of the reported event was due to an intrinsic defect in the valve, as supported by review of the valve's device history record and the analysis performed.The cause of the reported event remains unknown.

• Brand Name: 21MM AORTIC EXPD CUFF MA STERS
• 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 ; 6517564470
• MDR Report Key: 6566558
• MDR Text Key: 75132767
• Report Number: 2648612-2017-00057
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 05/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2003
• Device Model Number: 21AECJ-502
• Device Catalogue Number: 21AECJ-502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/1998
• 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
• Patient Age: 77 YR