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

Model Number ESP100-19

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Aortic Regurgitation (1716); Chest Pain (1776)

Event Date 11/10/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The investigation results will be provided in a subsequent submission.

Event Description

On an unknown date, a 21mm epic supra valve w/flexfit was implanted in the patient's aortic position with non-everting mattress suture technique using pledgets.An abbott sizer was used in the surgery.On (b)(6) 2020, the epic valve was explanted, replaced with an inspiris resilia aortic valve(manufacturer: edwards lifesciences).Upon explant, the valve was confirmed to be torn.It was reported also that the valve got damaged on the leaflet upon explant.The patient is stable postoperatively.The serial#, etc.Will be updated if information is obtained on a later date.

Manufacturer Narrative

Additional information sections: d4, d9, h2, h3, h6, h10.Explant was reported due to stenosis and regurgitation.Only one excised cusp along with the stent and part of the other three cusps were received, which were examined.It was found that the cusps had been previously excised.A calcification was present in what remained of cusp 3.Thinning, loss of collagen fibers, and degenerative changes were present in what remained of all three cusps.No acute inflammation was present.Based on what was received, the cause of the reported event could not be conclusively determined.

• Brand Name: EPIC SUPRA VALVE W/FLEXFIT
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA); rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 11029127
• MDR Text Key: 222091323
• Report Number: 3001883144-2020-00127
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESP100-19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention