MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC SUPRA VALVE W/FLEXFIT; HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number UNK EPIC SUPRA VALVE W/FLEXFIT

Device Problem Degraded (1153)

Patient Problem Aortic Valve Stenosis (1717)

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

The research article "mid-term results of s m epic supra aortic valve for severe aortic valve stenosis and its hemodynamics" was reviewed.This research article is a retrospective study with the goal to investigate the mid-term results and hemodynamics of epic supra aortic valve for aortic valve stenosis.The device associated with this study was sjm epic supra.The conclusion of this study was that structural valve deterioration was experienced in patients who had undergone aortic valve replacement with sjm epic supra aortic valve for more than 5 years; increased mpg and decreased eoai over time may also be associated with the development of prosthetic valve dysfunction.[primary author: tatsuhito wakami, youth department of cardiovascular surgery, hyogo prefectural amagasaki general medical center, hyogo, japan].

Manufacturer Narrative

Summarized patient outcomes/complications of epic supra valve implant were reported in a research article in a subject population of 65 patients.Four of the 65 patients experienced structural valve deterioration after 5 years of implant.Pannus was found under the valve.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.The cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: EPIC SUPRA VALVE W/FLEXFIT
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL LTDA. REG#3001883144; 1301rua profvieira demendonça; bairro engenho nogueira 31.31 0-26; BR 31.310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15974349
• MDR Text Key: 305413445
• Report Number: 2135147-2022-02528
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK EPIC SUPRA VALVE W/FLEXFIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2023
• 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): Required Intervention; Hospitalization