MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC SUPRA VALVE W/FLEXFIT; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number ESP200-19

Device Problems Patient-Device Incompatibility (2682); Device Stenosis (4066)

Patient Problem Valvular Stenosis (2697)

Event Date 01/20/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2023 a 19mm epic plus valve was implanted into a patient.On (b)(6) 2023 it was noted that the patient had a high gradient of 62; the patient was asymptomatic.No stenosis was observed.Blood thinners was provided.The patient was reported to have been discharged.

Manufacturer Narrative

An event of high gradient was reported.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 also 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.H6: device codes 2199 and 2682 were removed.

• Brand Name: EPIC SUPRA VALVE W/FLEXFIT
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16287642
• MDR Text Key: 308705920
• Report Number: 2135147-2023-00371
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067033116
• UDI-Public: 05415067033116
• 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: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESP200-19
• Device Catalogue Number: ESP200-19
• Device Lot Number: BR00033643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2022
• 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): Required Intervention