MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA (CVD) EPIC SUPRA VALVE W/FLEXFIT; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number ESP100-19

Device Problem Torn Material (3024)

Patient Problem Aortic Regurgitation (1716)

Event Date 08/01/2017

Event Type  Injury  

Event Description

On (b)(6) 2016, a double valve replacement was performed and this 19 mm epic supra valve was implanted in the aortic position and a 29 mm epic valve was implanted supra-annularly in the mitral position using non-everting mattress sutures and pledgets.On an unknown date, aortic regurgitation was observed at a routine follow-up.On (b)(6) 2017, the 19 mm epic supra valve (aortic) was explanted and a 19 mm magna ease valve was implanted.Ex vivo,a non-coronary cusp of the 19 mm epic supra valve was reported to contain an oval-shaped perforation.Per report, the surgeon suspected the perforated cusp either was due to the patient's history of infection or occurred at implant.The 29 mm epic mitral valve remains implanted.

Manufacturer Narrative

The results of this investigation concluded the returned 19mm epic supra valve contained acute and chronic endocarditis.The base of cusp 1 contained a vegetation with acute and chronic inflammation, and disruption of the cusp architecture.Cusps 1 and 3 contained tears and degenerative changes.There was thin layer of fibrous pannus on the inflow surface of cusp 3.Special stains were negative for organisms and there was no significant calcifications were present in the valve.A review of the device history record showed the device met specifications prior to leaving abbott manufacturing facilities.There was no evidence found to suggest the cause of the endocarditis, tears, or pannus were due to an intrinsic defect in the valve, as supported by review of the valve's device history record and the analysis performed.The cause of the reported event remains unknown.

• Brand Name: EPIC SUPRA VALVE W/FLEXFIT
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (CVD); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA (CVD); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6800246
• MDR Text Key: 82897172
• Report Number: 3008452825-2017-00179
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: ESP100-19
• Device Catalogue Number: ESP100-19
• Device Lot Number: 5172491
• Other Device ID Number: 05414734027458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2017
• Initial Date FDA Received: 08/17/2017
• Supplement Dates Manufacturer Received: 08/25/2017; 09/15/2017
• Supplement Dates FDA Received: 10/05/2017; 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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
• Patient Age: 74 YR