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

Catalog Number E100-33M

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Endocarditis (1834); Unspecified Infection (1930)

Event Date 11/09/2022

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 an unknown date one year ago, a 33mm stented porcine,mit,epic was successfully implanted.On (b)(6) 2022, the patient underwent a procedure to evacuate a large vegetation from the leaflets of the valve due to bacterial infection.The patient was admitted to the coronary care unit and intubated for the procedure.Angiovac system was used to retrieve pieces of the growth from the valve.A sentinel filter was deployed during the procedure for cerebral protection.The procedure was successful and the patient returned to the coronary care unit to be extubated.The physician reported there was no increased mitral regurgitation post-procedure.The mitral valve left in place and functioning same as prior to procedure.The patient was reported to be in stable condition.

Manufacturer Narrative

An event of a procedure being performed to evacuate a large vegetation from the leaflets of a valve was reported.A returned device assessment could not be performed as the device was not returned for analysis.Information from field indicated that the mitral valve was left in place and functioning same as prior to procedure.Field believed the cause of the vegetation was bacterial infection.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.H6 device codes 2682 patient device incompatibility removed.H6.Health effect - clinical code 1834 endocarditis removed.

Event Description

N/a.

• 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: 15886678
• MDR Text Key: 304530509
• Report Number: 2135147-2022-02269
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: E100-33M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 81 YR
• Patient Sex: Male