MAUDE Adverse Event Report: ST JUDE MEDICAL SJM EPIC STENTED TISSUE VALVE

Model Number EL-25A

Device Problem Material Perforation (2205)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/16/2013

Event Type  Injury  

Event Description

The info provided to sjm indicated a patient underwent aortic valve replacement with a 25mm sjm epic stented valve (model: e100-25a, serial: unk) in 2009.The valve was perforated during the explant procedure.The patient is reported to be doing well post-procedure.

• Brand Name: SJM EPIC STENTED TISSUE VALVE
• Manufacturer (Section D): ST JUDE MEDICAL; belo horizonte
• Manufacturer Contact: denise johnson, rn ; caixa postal 106; belo horizonte ; BR ; 6517564470
• MDR Report Key: 3631905
• MDR Text Key: 15933242
• Report Number: 3001743903-2014-00004
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P040021
• 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
• Report Date: 12/16/2013

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 Model Number: EL-25A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/06/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2013
• Initial Date FDA Received: 01/10/2014
• Was Device Evaluated by Manufacturer?: No
• 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: 57 YR
• Patient Weight: 70