MAUDE Adverse Event Report: ST. JUDE MEDICAL BRASIL LTDA. EPIC SUPRA VALVE W/FLEXFIT; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number ESP100-21

Device Problems Leak/Splash (1354); Material Perforation (2205)

Patient Problem Aortic Regurgitation (1716)

Event Date 01/20/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2011, an aortic valve replacement (avr) was performed due to aortic stenosis (as) caused by calcification and this 21mm epic valve was implanted utilizing non-everting mattress sutures.Concomitantly, coronary artery bypass grafting (cabg) was performed.On (b)(6) 2017, re-do avr was performed due to grade 2 to 3 aortic regurgitation (ar).Preoperatively, the patient's peak pressure gradient (ppg) was reported to be 46 mmhg and the mean pressure gradient (mpg) was 27 mmhg.Upon explant of this valve, a perforation was found in center of the valve.The suture tails were invisible and completely covered with intima.A 21mm tissue valve was another manufacturer was implanted.The patient was in stable condition postoperatively.

Manufacturer Narrative

The results of this investigation concluded tearing was observed in all three cusps.Thinning and a loss of collagen was found along the base of all three cusps.No acute inflammation or significant calcification was found.No evidence was found to suggest the cause of the tears and thinning and loss of collagen fibers was 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 BRASIL LTDA.; caixa postal 106; belo horizonte 34000 -000; BR 34000-000
• Manufacturer (Section G): ST. JUDE MEDICAL BRASIL LTDA.; caixa postal 106; belo horizonte 34000 -000; BR 34000-000
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6334310
• MDR Text Key: 67535408
• Report Number: 3001743903-2017-00005
• 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
• Report Date: 01/24/2017

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: 11/05/2014
• Device Model Number: ESP100-21
• Device Catalogue Number: ESP100-21
• Device Lot Number: 3435226
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2017
• Initial Date FDA Received: 02/15/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/06/2010
• 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): Hospitalization; Required Intervention
• Patient Age: 79 YR