MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. (CS) SJM MASTERS SERIES VALVE EXPANDED CUFF; HEART-VALVE, MECHANICAL

Model Number 23MECJ-502

Device Problem Perivalvular Leak (1457)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 06/08/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, a 19mm regent mechanical heart valve was implanted in the aortic position and a 23mm masters series mechanical heart valve was implanted in the mitral position.On june 8, re-do surgery was performed on the mitral valve due to paravalvular leakage (pvl) secondary to a suspected calcified and torn native annulus.Two additional sutures with felt pledgets were required for the mechanical mitral valve which resolved the pvl.The mitral valve remains implanted.As a result of the pledgets, the aortic valve area became narrower and it was necessary to explant the 29mm regent valve and implant a smaller 17mm regent valve.

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.This report is related to mdr 2648612-2015-00012 for the 19mm regent valve that was explanted.

• Brand Name: SJM MASTERS SERIES VALVE EXPANDED CUFF
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC. (CS); p.o. box 998; lot 20 b st.; caguas, puerto rico 0072 5
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. (CS); p.o. box 998; lot 20 b st.; caguas, puerto rico 0072 5
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4853897
• MDR Text Key: 19986956
• Report Number: 2648612-2015-00013
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/11/2019
• Device Model Number: 23MECJ-502
• Device Catalogue Number: 23MECJ-502
• Device Lot Number: 4466753
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2014
• 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