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

Model Number TF-23A

Device Problems Calcified (1077); Obstruction of Flow (2423)

Patient Problems Aortic Valve Stenosis (1717); Bradycardia (1751); Chest Pain (1776); Death (1802); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Pulmonary Edema (2020); Renal Failure (2041); Cardiogenic Shock (2262)

Event Type  Death  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2014 a 23mm trifecta valve was implanted.On (b)(6) 2019, the patient presented to the hospital with chest pain and shortness of breath and was admitted to the hospital.On (b)(6) 2019, a transthoracic echocardiogram was performed and calcification on the leaflets and severe aortic stenosis was noted.On (b)(6) 2019, the patient was discharged with plans for a ct scan the next day for anticipated explant.On (b)(6) 2019, the patient presented to follow-up appointment and was experiencing shortness of breath, hypotension and increased creatine.The patient was admitted into the hospital.On (b)(6) 2019, the patient collapsed in the hospital room and was prepped for emergency surgery.The patient became bradycardia and unresponsive.On (b)(6) 2019, the patient expired due to aortic valve stenosis and acute renal failure, pulmonary edema and cardiogenic shock.

Manufacturer Narrative

Additional information: h6.An event of chest pain, shortness of breath, calcification, stenosis, hypotension, bradycardia and patient death due to valve stenosis, renal failure, pulmonary edema, and cardiogenic shock was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• MDR Report Key: 10270088
• MDR Text Key: 198686585
• Report Number: 3007113487-2020-00021
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052030
• UDI-Public: 05414734052030
• Combination Product (y/n): N
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2015
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Device Lot Number: 4351298
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 71 YR