MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EPIC¿; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	MITRAL
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Epic valve was opened and passed to scrub rn who rinsed with saline and passed to field.One suture needle placed in valve when doctor requested new epic valve, same size.Per doctor, there was a "hole in the skirt".Notified another staff member and packaged valve per their instructions.Needle still in valve, valve in specimen cup and double bagged.Placed in larger bag with all packaging material and labeled with biohazard stickers.

• Brand Name: EPIC¿
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 county road b, east; st. paul MN 55117
• MDR Report Key: 8174992
• Report Number: 8174992
• Device Sequence Number: 1747432
• Product Code: LWR
• UDI-Device Identifier: 05414734055598
• UDI-Public: (01)05414734055598(17)211129(91)100040609(30)01
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/30/2018
• Report Date (Section F): 11/30/2018

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 Model Number: MITRAL
• Device Catalogue Number: E100-29M-00
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/30/2018