MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC STENTED PORCINE HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number E100-31M

Device Problems Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)

Patient Problems Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 08/04/2022

Event Type  Injury  

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) 2019, a 31mm epic valve was implanted.The valve annulus sizing was 31mm.In (b)(6) 2022, echocardiogram examination revealed mild to moderate mitral regurgitation without subjective symptoms.In (b)(6) 2022, the patient presented with mild heart failure and shortness of breath on exertion, and echocardiogram revealed moderate mitral regurgitation.On (b)(6) 2022, the 31mm epic valve was explanted, and it was noted that there was a hole in the leaflet.The negative pressure from the regurgitation had caused the leaflet to swell up.There was also reflux from the central part of the valve.The valve was replaced with a 31mm sjm masters series valve expanded cuff.The patient was reported as stable.

Manufacturer Narrative

Explant due to mild heart failure, shortness of breath on exertion and moderate mitral regurgitation was reported.The investigation found thinning of base and tears in cusp 1.Cusp 1 was torn.Native valve cusps were adherent to sewing cuff.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.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, which could have contributed to the formation of the tear.The tears could have contributed to the reported regurgitation.H6 medical device problem code: 4008 code removed.

• Brand Name: EPIC STENTED PORCINE HEART VALVE
• 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 #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15331636
• MDR Text Key: 299039761
• Report Number: 2135147-2022-00965
• 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: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2022
• Device Catalogue Number: E100-31M
• Device Lot Number: 6713611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2018
• 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): Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Weight: 55 KG