MAUDE Adverse Event Report: ST. JUDE MEDICAL, BRASIL LTDA. EPIC SUPRA VALVE W/FLEXFIT; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number ESP100-27

Device Problem Microbial Contamination of Device (2303)

Patient Problem Endocarditis (1834)

Event Date 11/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2016, a 27 mm epic valve was implanted.On (b)(6) 2016, the valve required explantation due to confirmed severe endocarditis and a redo bentall procedure was performed using a 23 mm trifecta valve with a 26 mm valsalva graft.The patient was stable post-procedure without inotrope support but required atrial pacing for sinus bradycardia.

Manufacturer Narrative

The results of this investigation concluded that both a tear and horizontal fold were observed in cusp 2.Focal inflow thrombus was found on the inflow surface of cusp 2.Focal acute inflammation was found in the sewing cuff material adjacent to cusp 3.A gram stain was negative for organisms.No evidence was found to suggest the cause of the observed tear, fold, thrombus, and acute inflammation 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: EPIC SUPRA VALVE W/FLEXFIT
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer (Section G): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6165539
• MDR Text Key: 62081308
• Report Number: 3001883144-2016-00079
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P040021
• 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: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2019
• Device Model Number: ESP100-27
• Device Catalogue Number: ESP100-27
• Device Lot Number: BR00002956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2015
• 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: 58 YR