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

Catalog Number	ESP200-21
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2023, a 21mm epic plus supra aortic valve was chosen for implant.After implanting the valve, the physician noted via transesophageal echocardiography (tee) the valve "appeared to leak" and had difficultly closing.A decision was made to explant the valve.The 21mm epic plus supra aortic valve was replaced with a 19mm epic plus supra aortic valve.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay in the procedure.The patient status was reported as stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
The reported event of regurgitation could not be confirmed.No anomalies were found with the valve cusps, and functional testing at the time of manufacturing and upon return to abbott indicated the valve functioned normally.This test ensures proper cuspal coaptation and hemodynamic performance.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.In the absence of any evidence of valve anomaly that may impact valvular function, the reported event is consistent with a non-structural valve dysfunction.A non-structural valve dysfunction (nsvd) is a known potential complication of valve replacement surgery as outlined in the instructions for use.Nsvd is commonly attributed to implant-related technical factors such as inappropriate sizing or positioning, entrapment by suture, stent deformation, or mishandling of the leaflet tissue.In this case there is no evidence of entrapment by suture, or stent deformation that could explain the observed intra-operative valvular dysfunction.A smaller valve (19mm instead of 21mm) was successfully implanted, but there is no indication of inappropriate sizing.Temporary distortion of the stent due to external forces following closure where the stent is not permanently deformed may also potentially explain the observed intraoperative valvular dysfunction.However, since it is not possible to determine whether there was any temporary intra-operative stent deformation and none of the other potential causes for nsvd could be confirmed, the exact cause of the observed intra-operative valvular regurgitation cannot be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 17599042
• Report Number: 2135147-2023-03668
• Device Sequence Number: 17748002
• Product Code: LWR
• UDI-Device Identifier: 05415067033123
• UDI-Public: 05415067033123
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2023

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: ESP200-21
• Device Lot Number: BR00038187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2023
• 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: 75 YR
• Patient Sex: Female