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

Catalog Number E100-31M

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Pulmonary Edema (2020)

Event Date 12/13/2022

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) 2020, an 31 mm epic valve was implanted into a patient.On (b)(6) 2022, the patient presented at the hospital with acute pulmonary edema.It was noted by echocardiogram that the cusp of the device was torn, and the valve was explanted.A new 29mm non-abbott device was successfully implanted as replacement.The patient was reported to be recovering.

Manufacturer Narrative

An event of acute pulmonary edema and explant due to torn cusp was reported.The investigation found cusps 1 and 3 were torn.There was fibrous pannus ingrowth on the inflow surface of cusps 2 and 3.There was thin layer of fibrin on the outflow surface of cusp 1.There was severe degenerative changes on cusp 1 along with micro-calcifications.No acute inflammation was present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all manufacturing specifications.The cause of the tear could not be conclusively determined; however, the fibrous pannus ingrowth noted had the potential to induce increased stress on adjacent cusps and create an unbalanced stress relief distribution between all cusps during coaptation, leading to cusp tears and reduced durability.Additionally, the reported degenerative changes and micro-calcification may also have contributed to the cusp tear.

• Brand Name: EPIC¿ 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 #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: 16114931
• MDR Text Key: 306829152
• Report Number: 2135147-2023-00080
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2023
• Device Catalogue Number: E100-31M
• Device Lot Number: BR00022920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2019
• 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