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

Catalog Number E200-31M

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Respiratory Insufficiency (4462)

Event Date 08/14/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

Clinical information: crd_942 - summit, patient site id: (b)(6).It was reported that on 30 may 2023, an 31mm epic valve was successfully implanted in a mitral valve replacement procedure.On (b)(6) 2023, it was noted that began suffering from respiratroy insuffiency/failure and developed a complete white out of the left lung.The decision was made to a bronchoscopy and perform a tracheostomy change at patient's bedside.It was noted that there were thick secretions at the end of the tracheal tube, upper trachea, and the patient's left side/lung.It was also noted that the patient's airways were red and very friable.The decision was made to suction the secretions and send them for culture testing.On (b)(6) 2023, the patient was suffering from respiratory distress and absent left lung sound.The decision was made to place the patient on positive airway pressure and transfer them to the intensive care unit (icu).In the icu the patient underwent a deep nasal suction, ventilated and oxygenated.The patient was also placed on a 5 day regimen of an empirical antibiotic (meropenem) for potential aspiration pneumonia.The patient was hospitalized due to these events.

Manufacturer Narrative

An event of the respiratory insufficiency was reported.A returned device assessment 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.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.

• 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: 18310392
• MDR Text Key: 330279985
• Report Number: 2135147-2023-05435
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067033093
• UDI-Public: 05415067033093
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: E200-31M
• Device Lot Number: BR00035210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2022
• 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): Other; Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 96 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White