MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC¿ SUPRA VALVE (AORTIC); HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number ESP100-19

Device Problems Patient-Device Incompatibility (2682); Material Split, Cut or Torn (4008); Central Regurgitation (4068)

Patient Problems Aortic Valve Stenosis (1717); Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 11/01/2023

Event Type  Injury  

Event Description

It was reported that in an unknown date epic stented porcine heart valve was successfully implanted.Due to aortic regurgitation, the valve was removed.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2014, a 19mm epic supra valve was successfully implanted with two-vessel coronary artery bypass grafting for aortic stenosis and coronary artery stenosis.Around 2019, aortic regurgitation (ar) was noted to be mild, and no particular symptoms were observed.On (b)(6) 2022, ar was noted to be mild to moderate.In 2023 (date unknown), symptoms of shortness of breath on exertion appeared and worsened.Upon examination, moderate-severe ar and moderate aortic stenosis (as) (vmax 3.5m/s) were observed.The patient was diagnosed with heart failure due to aortic stenosis and regurgitation.On (b)(6) 2023, the 19mm epic valve was explanted and a 21mm non-abbott valve was implanted.The patient is reported to be stable.It was stated by the physician that in the intraoperative finding, the sclerosis of the leaflets was mild, but the non-coronary cusp was prolapsed.It was thought to be caused by a slight tear of the leaflets.In addition, a slight subvalvular pannus was observed.

Manufacturer Narrative

Explant due to shortness of breath on exertion, heart failure due to aortic stenosis and regurgitation was reported.Also reported was that the non-coronary cusp was prolapsed and there was slight sub-valvular pannus.The investigation found all three cusps were torn.There were mild degenerative changes and cusp thinning noted on cusps 1 and 3.No inflammation or significant calcifications were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of tear could not be conclusively determined.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 degenerative changes at the tear site, which could have contributed to the formation of the tear.

• Brand Name: EPIC¿ SUPRA VALVE (AORTIC)
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL LTDA. REG#3001883144; 1301rua profvieira demendonça; bairro engenho nogueira 31.31 0-26; BR 31.310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18209144
• MDR Text Key: 329003661
• Report Number: 2135147-2023-05180
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2017
• Device Catalogue Number: ESP100-19
• Device Lot Number: 4489646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2013
• 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): Other; Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male