MAUDE Adverse Event Report: ST. JUDE MEDICAL MITRAL; EPIC VALVE

Model Number	E100-31M-00
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/29/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Pt scheduled for avr/mvr+/- tvr.After replacing the mitral valve w31 mm, st jude medical epic valve, as the valve was being treated, a tear was noted in one of the leaflets.The valve was explanted.All 10 of the cor-knots and all 10 of the pledgets from the sutures used to secure the valve in place were removed and discarded on inspecting the explanted valve the doctor noticed that there was a fold in one of the leaflets along the edge of the sewing ring.

• Brand Name: MITRAL
• Common Device Name: EPIC VALVE
• Manufacturer (Section D): ST. JUDE MEDICAL; st. paul MN
• MDR Report Key: 6232393
• Report Number: MW5067086
• Device Sequence Number: 813192
• Product Code: DYE
• UDI-Device Identifier: 05414734055604
• UDI-Public: 05414734055604
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/25/2019
• Device Model Number: E100-31M-00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR