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

Catalog Number ESP100-21

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2024

Event Type  malfunction  

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)2024, a 21mm epic supra valve was chosen for a minimally invasive aortic valve surgery (micsavr).The annular dimension of the native valve was 20.8mm.During procedure, it was noted that the device was tight and did not fall in the annulus and the physician felt resistance felt while parachuting.The device was removed and a new 19mm non- abbott valve was implanted while patient was on bypass.There was no delay in the procedure.The patient was reported stable.

Manufacturer Narrative

An event of valve being tight and resistance felt while parachuting was reported.Information from field indicated that the annular dimension of the native valve was 20.8 mm and the 21 mm valve was removed and downsized to 19 mm non-abbott valve.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.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.

Event Description

It was reported that on (b)(6) 2024, a 21mm epic supra valve was chosen for a minimally invasive aortic valve surgery (micsavr).The annular dimension of the native valve was 20.8mm.During procedure, it was noted that the device was tight and did not fall in the annulus and the physician felt resistance felt while parachuting.The device was removed and a new 19mm non- abbott valve was implanted while patient was on bypass.There was no delay in the procedure.The patient was reported stable.

• Brand Name: EPIC¿ SUPRA VALVE (AORTIC)
• 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: 18944650
• MDR Text Key: 338434876
• Report Number: 2135147-2024-01257
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ESP100-21
• Device Lot Number: 10099694
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2023
• 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 Age: 21 YR
• Patient Sex: Female