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

Model Number 21VAVGJ-515

Device Problem Entrapment of Device (1212)

Patient Problems Death (1802); Thrombus (2101)

Event Date 10/14/2014

Event Type  Death  

Event Description

An aortic valve replacement procedure was performed and another manufacturer's valve was implanted with subsequent intraoperative complications.The valve was removed and this aortic valved graft was implanted.After 10+ hours on bypass, cross clamp was removed.The heart initially ejected in normal fashion, the valve leaflets functioned normally, then the leaflets became impeded.It was reported the leaflets were possibly entrapped with thrombus due to extended pump time.The patient expired on the table.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The results of the investigation concluded both leaflets opened and closed completely and with ease when manipulated.A section of myocardium was adherent to the sewing cuff, and the bottom rim of the valve orifice contained a chip, which may have occurred at explant.No significant calcifications were observed and gram stain was negative for organisms.No evidence was found to suggest there was 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: SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT
• 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 0072 5
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 0072 5
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 4225529
• MDR Text Key: 5060354
• Report Number: 2648612-2014-00050
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: 21VAVGJ-515
• Device Catalogue Number: 21VAVGJ-515
• Device Lot Number: 4292149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2014
• Initial Date FDA Received: 11/04/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2013
• 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; Hospitalization; Required Intervention
• Patient Age: 61 YR