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

Model Number	TF-27A
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	06/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2011, a 27 mm trifecta valve was implanted.On (b)(6) 2018, the valve was explanted due to stenosis and an edwards lifesciences inspiris valve was implanted.The surgeon reported the trifecta was 7 years old at the time of explant.The patient is reported to be recovering.
Additional Manufacturer Narrative
An event of stenosis was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown; however, information from the field indicated "the trifecta valve was 7 years old at the time of explant.".

• Brand Name: SJM TRIFECTA VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• MDR Report Key: 7688539
• Report Number: 3007113487-2018-00014
• Device Sequence Number: 13654524
• Product Code: LWR
• UDI-Device Identifier: 05414734052054
• UDI-Public: 05414734052054
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/06/2013
• Device Model Number: TF-27A
• Device Catalogue Number: TF-27A
• Device Lot Number: 3369120
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 07/15/2018
• Supplement Report FDA Received Date: 09/23/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 61 YR