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

Catalog Number	ESP200-23
Medical Device Problem Codes	Nonstandard Device (1420); Incomplete Coaptation (2507)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024, a 23mm epic valve was selected for implant.During the procedure, it was noted that when the valve was implanted that the leaflets didn't coapt properly.The device was removed and replaced with a non-abbott valve, while still on bypass, to resolve the event.The physician said that the profile of the valve does not match the sizer.There was no clinically significant delay and the patient remained hemodynamically stable throughout the procedure.There were no adverse consequences due to the performance of the device.The patient is stable.
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of incomplete coaptation and nonstandard device was reported.The valve was returned to abbott for analysis.All three cusps were flexible and contained no tears, perforations or anomalies.All cusps were mobile when manually manipulated.Functional testing at the time of manufacturing and upon return to abbott indicated that the valve functioned normally.During this test, which ensures proper cuspal coaptation and hemodynamic performance, the valve was placed in a pulse duplicator filled with saline.The conditions included a beat rate of 70 ± 1 bpm, a flow rate of 5.0 ± 0.2 lpm, and a mean aortic pressure of 100 +10/-0 mmhg.Under these conditions, the leaflets appeared to coapt such that the regurgitant fraction value was 1.9%.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2024, a 23mm epic valve was selected for implant.During the procedure, it was noted that when the valve was implanted that the leaflets didn't coapt properly.The device was removed and replaced with a non-abbott valve, while still on bypass, to resolve the event.The physician said that the profile of the valve does not match the sizer.There was no clinically significant delay and the patient remained hemodynamically stable throughout the procedure.There were no adverse consequences due to the performance of the device.The patient is stable.

• Brand Name: EPIC¿ SUPRA VALVE (AORTIC)
• Common Device Name: 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: 20096580
• Report Number: 2135147-2024-04218
• Device Sequence Number: 7748184
• Product Code: LWR
• UDI-Device Identifier: 05415067033130
• UDI-Public: (01)05415067033130(17)271108(10)BR00041591
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ESP200-23
• Device Lot Number: BR00041591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Unknown
• Patient Weight: 73 KG