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

Catalog Number E100-25M

Device Problems Incomplete Coaptation (2507); Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008); Central Regurgitation (4068)

Patient Problems Dyspnea (1816); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451); Insufficient Information (4580)

Event Date 10/13/2023

Event Type  Injury  

Event Description

It was reported that on an unknown date (3 years ago), a 25mm epic mitral mechanical valve was successfully implanted.On (b)(6) 2023, the 25mm mechanical valve was explanted and a replacement non-abbott device was implanted.During inspection of the explanted 25mm epic valve, a tear was observed at the lower part of the commissure leaflet.The patient is reported to be stable.

Manufacturer Narrative

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

Manufacturer Narrative

Explant due to mitral regurgitation was reported.The investigation confirmed that a tear was present in cusp 1.There was outflow thrombus on cusp 2.No acute 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.Thinning was noted at the tear site, which could have contributed to the formation of the tear.The tear and thrombus noted could have contributed to the reported regurgitation.There are a number of patient-specific and anatomical factors that could lead to thrombus formation, such as not having anticoagulation prescribed or the patient having a blood disorder resulting in hypercoagulability.In this case it was noted that the patient was prescribed anticoagulants and they did not have any blood disorders.The cause of the thrombus could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.H6 health effect - clinical code: code 4580 removed.

Event Description

It was reported that on (b)(6) 2018, a 25mm epic mitral valve was successfully implanted.On (b)(6) 2023, the patient was rushed to the hospital due to difficulty breathing and was diagnosed with acute heart failure.Upon closer examination, severe mitral regurgitation (mr) was found.A surgery was performed to explant the 25mm valve and a replacement non-abbott device was implanted.During inspection of the explanted 25mm epic valve, a tear was observed at the lower part of the commissure leaflet.It was noted that the length of the leaflet, which thrombi being adhered to, is specifically smaller than other leaflets.The physician measured the length of each leaflet and that of the leaflet being attached thrombi-like substance was 9mm and the other two leaflets were 11mm.The physician is suspecting that the reported event possibly attributed to limited leaflet mobilities caused by the different length of leaflets.The patient is reported to be stable.

• Brand Name: EPIC¿ VALVE (MITRAL)
• 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: 18093507
• MDR Text Key: 327649553
• Report Number: 2135147-2023-04924
• 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: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2021
• Device Catalogue Number: E100-25M
• Device Lot Number: BR00014600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2017
• 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: 75 YR