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

Model Number E200-29M

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Endocarditis (1834); Unspecified Infection (1930); Sepsis (2067)

Event Date 01/16/2023

Event Type  Death  

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) 2023, a 29mm epic plus mitral was implanted.At the end of 2nd week of implantation the patient experienced fever and was admitted to the hospital.It was found that the patient had endocarditis and was later diagnosed with septic emboly in brain.The patient had no history of endocarditis and was in stable condition post implant.It was reported that the patient passed away in one week on (b(6) 2023.The cause of death was endocarditis, sepsis and intracranial bleeding.No additional information was provided.

Manufacturer Narrative

An event of fever, endocarditis, septic emboly in brain and patient death was reported.Information from field indicated that the patient had no history of endocarditis and was in stable condition post-implant.Field indicated that the cause of death was endocarditis, sepsis and intra cranial bleeding.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: EPIC PLUS
• 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: 16587455
• MDR Text Key: 311733761
• Report Number: 2135147-2023-01286
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067033086
• UDI-Public: 05415067033086
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E200-29M
• Device Catalogue Number: E200-29M
• Device Lot Number: BR00033213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• 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): Death