MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (CS-WOODRIDGE) TRIFECTA STENTED TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Device Problems Backflow (1064); Gradient Increase (1270); Obstruction of Flow (2423)

Patient Problems Atrial Fibrillation (1729); Regurgitation (2259); Stenosis (2263); Complete Heart Block (2627)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, five patients had a valve-in-valve performed to replace a trifecta valve due to stenosis, regurgitation, and high gradient.The results of the investigation are inconclusive since a valve-in-valve was performed and the device was not accessible for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported through a research article identifying trifecta that may be related to a valve in valve procedure.Specific patient information is documented as unknown.Details are listed in the article, titled [valve-in-valve implantation using the acurate neo in degenerated aortic bioprostheses].It was reported from the study that 85 patients from 14 centers in europe and (b)(6) were implanted with a variety of make and model of tissue heart valves.Five of the patients were originally implanted with a trifecta valve.After a median time of 9.2 years (range 1.1 to 18.1 years), stenosis, regurgitation, and high gradient were observed and the patients were treated with valve in valve procedure using the acurate neo.The major complications for the 30-day outcomes were reported to be vascular complication (5%), bleeding (5%), kidney injury (2%), permanent pacemaker implantation (1%), left bundle branch block (2%), new onset atrial fibrillation (2%), and stroke (1%).

• Brand Name: TRIFECTA STENTED TISSUE VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); 177 east county road b; st. paul MN 55117
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9482181
• MDR Text Key: 171661651
• Report Number: 3007113487-2019-00040
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Required Intervention