MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. MASTERS SERIES CAVGJ,AUS TRALIAN,23MM; AORTIC VALVED GRAFT

Model Number 23CAVGJ-514 00

Device Problem Obstruction of Flow (2423)

Patient Problems Corneal Pannus (1447); Aortic Insufficiency (1715)

Event Type  Injury  

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.

Event Description

An sjm masters series valved graft was implanted on (b)(6) 2007.Due to pannus formation on the leaflets, the opening angle is now 60°.On (b)(6) 2016, the valve was explanted and replaced with a perceval sutureless valve and the patient is reported to be stable.

• Brand Name: MASTERS SERIES CAVGJ,AUS TRALIAN,23MM
• Type of Device: AORTIC VALVED GRAFT
• 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: 5878545
• MDR Text Key: 52190897
• Report Number: 2648612-2016-00080
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P810002/S056
• 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
• Report Date: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2011
• Device Model Number: 23CAVGJ-514 00
• Device Catalogue Number: 23CAVGJ-514 00
• Device Lot Number: 0002096025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2006
• 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: 75 YR