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

Model Number ESP100-21

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 11/04/2014

Event Type  Injury  

Manufacturer Narrative

The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with sjm specifications and procedures.The results of this investigation concluded fibrous thickening of all cusps and outflow thrombus on all cusps.A fold was observed in cusp 3, but it is unknown if this is processing artifact or a true retraction of the cusp.Special stains revealed gram positive cocci on all cusps.The organisms were limited to the surface of the tissue and there was no associated inflammation.The organisms were likely a contaminant.No acute inflammation or significant calcifications were present.There was no evidence found to suggest the cause of the fibrin, thrombus, and cuspal fold were 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.

Event Description

The patient's tissue valve was explanted due to calcification.A mechanical heart valve was implanted.

Manufacturer Narrative

(b)(4).

• Brand Name: EPIC SUPRA VALVE W/FLEXFIT
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL BRASIL LTDA. (NOVA LIMA); caixa postal 106; edificio #44b, calle 0, avenida 2, coyol; belo horizonte 3400 0-00; BR 34000-000
• Manufacturer (Section G): ST. JUDE MEDICAL BRASIL LTDA. (NOVA LIMA); caixa postal 106; edificio #44b, calle 0, avenida 2, coyol; belo horizonte 3400 0-00; BR 34000-000
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4241610
• MDR Text Key: 12831586
• Report Number: 3008452825-2014-00045
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PP040021
• 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,Followup
• Report Date: 11/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/06/2015
• Device Model Number: ESP100-21
• Device Catalogue Number: ESP100-21
• Device Lot Number: 3582575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2011
• 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