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

Catalog Number ESP100-23

Device Problem Material Split, Cut or Torn (4008)

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

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 (b)(6) 2022, a 23mm aortic epic supra valve was selected for implant.During the procedure, after the valve was implanted, an evident laminar tearing on one of the valve leaflets was observed.The physician extended the extracorporeal circulation time to remove the valve and implanted a new 23mm aortic epic supra valve.Since the tearing was detected before closing the aorta, no intraoperative echocardiogram was performed.It was noted that the patient was in stable post-operative condition.The patient was transferred into the intensive care unit (icu) with only nitroprusside, which was quickly suspended.No patient consequences were reported.

Manufacturer Narrative

An event of a tear being found after the valve was implanted was reported.The investigation confirmed that the valve contained a tear/incision.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications, including functional specifications for leaflet coaptation and visual inspection for damage.The cause of the tear could not be conclusively determined; however, it appeared to be consistent with a sharp object coming into contact with the cuspal tissue.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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 (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: 15886664
• MDR Text Key: 304530599
• Report Number: 2135147-2022-02271
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 01/23/2023

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: ESP100-23
• Device Lot Number: BR00033719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2022
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 77 KG