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

Model Number ESP100-19

Device Problems Backflow (1064); Calcified (1077); Material Split, Cut or Torn (4008)

Patient Problems Aortic Regurgitation (1716); Calcium Deposits/Calcification (1758)

Event Date 11/30/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

On (b)(6) 2016, a 19mm epic supra valve w/flexfit was implanted in the patient's aortic position with the non-everting mattress suture technique using pledgets due to calcification.Severe calcification was confirmed on the annulus, and annular enlargement was performed also.An abbott sizer was used in the surgery.Severe aortic regurgitation was confirmed near the stent and the commissure on the echocardiogram which led to a re-do avr.The epic supra valve was explanted on (b)(6) 2020, replaced with a 19mm freestyle aortic valve(manufacturer: medtronic).Upon explant, tears were confirmed on the ncc and the lcc leaflets.The patient is in stable condition postoperatively.It was reported that the implant was performed by another surgeon at the hospital who has already retired, and therefore, the cause is unknown.The explant surgeon thinks the issue was due to both the valve and the implant procedure technique.

Manufacturer Narrative

Explant was reported due to aortic regurgitation.The investigation found that cusps 1 and 3 contained tears.These cusps were thin at the base.Degenerative changes were present in all three cusps.No inflammation or significant calcification were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.In the absence of any calcification or evidence for infection, the reported event is consistent with a non-calcific leaflet tear.A non-calcific leaflet tear is a form of structural valve deterioration (svd), which is a well-known complication from valve replacement surgery.A non-calcific leaflet tear is commonly attributed to increased operational leaflet stress but may also be related to biological factors which result in tissue degeneration characterized by loss of collagen.In this case, histological evaluation did demonstrate loss of collagen at the tear site, which could have contributed to the formation of the tear.

• Brand Name: EPIC SUPRA VALVE W/FLEXFIT
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (SH); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• MDR Report Key: 11076045
• MDR Text Key: 223709263
• Report Number: 3008452825-2020-00705
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2019
• Device Model Number: ESP100-19
• Device Lot Number: 5169630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR