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

Model Number	TF-27A
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Aortic Regurgitation (1716)
Date of Event	08/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of aortic regurgitation was reported.The results of the investigation are inconclusive since the device was not returned for analysis; however, two images were submitted for analysis.Based solely on the aforementioned images, one leaflet appeared to have torn away from a stent post.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
On (b)(6) 2014, a 27mm trifecta valve was implanted in a (b)(6) patient.Following the initial valve replacement, the patient underwent a total knee replacement which became infected.The patient presented on an unknown date with severe aortic regurgitation which was initially considered related to endocarditis following an infected knee.On (b)(6) 2018, the 27mm trifecta valve was explanted and a 25mm edwards magna ease was implanted, along with a tricuspid valve repair using a 28mm physio ring.There were no findings consistent with active or remote endocarditis; however, the non-coronary cusp of the trifecta valve was observed detached from the commissure in a linear fashion.The patient is reported discharged and doing well.

• 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: 8029138
• Report Number: 3007113487-2018-00025
• Device Sequence Number: 16502540
• Product Code: LWR
• UDI-Device Identifier: 05414734052054
• UDI-Public: 05414734052054
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/01/2018

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: 10/28/2015
• Device Model Number: TF-27A
• Device Catalogue Number: TF-27A
• Device Lot Number: 4351296
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 11/01/2018
• 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: 80 YR