MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT

Model Number 29VAVGJ-515

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 04/08/2017

Event Type  Death  

Manufacturer Narrative

An event of patient death was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Information received from abbott's patient device tracking indicated on (b)(6) 2017, a 29 mm sjm masters series valsalva aortic valved graft was implanted.Per report, the patient had a sentinel event 24 hours post-procedure and was brain dead.Additional information has been requested but no further information has been made available.

• Brand Name: SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT
• Type of Device: AORTIC VALVED GRAFT
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7123034
• MDR Text Key: 95021571
• Report Number: 3007113487-2017-00037
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: 29VAVGJ-515
• Device Catalogue Number: 29VAVGJ-515
• Device Lot Number: 4355966
• Other Device ID Number: 05414734009508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2013
• 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: 72 YR