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

Model Number ESP100-21

Device Problems Backflow (1064); Material Integrity Problem (2978); Material Split, Cut or Torn (4008)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717)

Event Date 06/02/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2011, a 21mm epic supra valve w/flexfit was selected for implant.On (b)(6) 2020, the patient presented to the hospital after she became aware of abnormal heart sounds.On (b)(6) 2020, the valve was explanted after severe aortic regurgitation and stenosis was confirmed on echocardiogram.The valve was replaced with a 21mm sjm regent heart valve w/flex cuff.Upon explant, a tear of the stent post was confirmed.The physician reported that the durability of the valve might have been affected by the patient's age at the time of implant.The patient was reported to be in stable condition.

Manufacturer Narrative

Correction: d3.Additional information: d10,g4,h2, h3, h6, h10.The tear, noted at explant following explant due to stenosis and regurgitation, was confirmed upon analysis.All cusps contained tears, with thinning of the tissue at their base.A micro calcification was noted in cusp 3.The annular suture line was disrupted.No inflammation was present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.Two videos of the explant procedure were received for analysis.During explant, tissue was removed from the inflow surface of the valve, which may have caused the reported damage at explant and appeared to align with the thin areas of cuspal tissue noted upon analysis.It is also unknown if this explant damage affected the severity of the tears.In the absence of any calcification or evidence of 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.Histological evaluation revealed mild loss of collagen at one of the tear sites, which could have contributed to the tear.Furthermore, if the tissue attached to the inflow surface of the valve prior to explant had the potential to narrow the flow of blood and induce increased stress on adjacent leaflets and create an unbalanced stress relief distribution between all leaflets during coaptation, leading to leaflet tears and reduced durability.

• Brand Name: EPIC SUPRA VALVE W/FLEXFIT
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL BRASIL LTDA. (NOVA LIMA); caixa postal 106; engenho nogueira - belo horizonte - mg; belo horizonte 34000 -000; BR 34000-000
• MDR Report Key: 10211592
• MDR Text Key: 197203021
• Report Number: 3001883144-2020-00055
• 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: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2014
• Device Model Number: ESP100-21
• Device Lot Number: 3400505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 56