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

Model Number E200-33M

Device Problems Patient-Device Incompatibility (2682); Central Regurgitation (4068)

Patient Problems Endocarditis (1834); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 11/08/2022

Event Type  Injury  

Event Description

It was reported that on an unknown date, a 33mm epic plus valve was successfully implanted in a patient.On (b)(6) 2022, it was noted that the patient was suffering from device related endocarditis.It was also noted that the patient had mitral regurgitation.The decision was made to explant and replace the 33mm epic plus valve is an unknown size non-abbott device.The patient status was reported as unknown.

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 an unknown date, a 33mm epic valve was successfully implanted in a patient.On (b)(6) 2022, it was noted that the patient was suffering from device related endocarditis.It was also noted that the patient had mitral regurgitation.The decision was made to explant and replace the 33mm epic valve with an unknown size non-abbott device.The patient status was reported as unknown.

Manufacturer Narrative

An event of regurgitation secondary to endocarditis was reported.The valve was received for investigation which found that cusps 1 and 2 were torn and contained calcifications.No inflammation was noted.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 the tears could not be conclusively determined; however, one of the tears was associated with calcifications.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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 PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16038099
• MDR Text Key: 306063820
• Report Number: 2135147-2022-02694
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734055611
• UDI-Public: 05414734055611
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2014
• Device Model Number: E200-33M
• Device Catalogue Number: E100-33M-00
• Device Lot Number: 3293641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 04/05/2023
• Supplement Dates FDA Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2010
• 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
• Patient Age: 64 YR
• Patient Sex: Male