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

Model Number	TF-29A
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	09/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of exertional dyspnea, mg of 44, two immobile cusps and the leaflets appearing thickened was reported.The results of the investigation are inconclusive since a valve-in-valve procedure was performed and the device was not accessible for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
9 october 2019: additional information received on 7 october 2019 reported that the patient was discharged on the 3rd post-operative day.On (b)(6) 2014, a 29mm trifecta valve was implanted.In early summer of 2019, the patient presented with exertional dyspnea and mg of 44.Tee showed two cusps of the valve were immobile and all leaflets seemed thickened.On (b)(6) 2019, a valve in valve was performed and a competitors 34mm evolut r was successfully implanted.

• Brand Name: SJM TRIFECTA VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 9182655
• Report Number: 3008452825-2019-00490
• Device Sequence Number: 2830763
• Product Code: LWR
• UDI-Device Identifier: 05414734052061
• UDI-Public: 05414734052061
• Combination Product (Y/N): N
• Initial Reporter Country: EN
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/11/2019

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: 01/13/2016
• Device Model Number: TF-29A
• Device Catalogue Number: TF-29A
• Device Lot Number: 4452754
• 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: 09/25/2019
• Initial Report FDA Received Date: 10/11/2019
• 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