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

Catalog Number	UNK EPIC STENTED PORCINE HV
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of explant of an epic valve seven years after implant was reported in a literature article.Information from the article indicated the explant was due to valve stenosis.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported stenosis could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
The article, ¿impella implantation as a bridge to surgery for repair of aorto-right ventricular fistula following prosthetic valve endocarditis: a case report¿, was reviewed.The article presented a case study of an 82-year-old male patient with symptomatic aortic stenosis.It was reported that on an unknown date, a 19mm epic valve was implanted.It was later reported 7 years later on an unknown date, a decision was made to explant the 19mm epic valve due to prosthetic valve dysfunction and replaced with a 23mm non-abbott valve.The article concluded in cases of limited end-organ function damage, even a short duration of impella support would be beneficial without the occurrence of complications.[the primary and corresponding author was masahiro tsutsui, department of cardiac surgery, asahikawa medical university, 078-8510 asahikawa, japan, with corresponding email: mt.0714.Cuniculus@gmail.Com].
Additional Manufacturer Narrative
An event of explant of an epic valve seven years after implant was reported in a literature article.Information from the article indicated the explant was due to valve stenosis.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported stenosis could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Literature attachment: article title "impella implantation as a bridge to surgery for repair of aorto-right ventricular fistula following prosthetic valve endocarditis: a case report"b1 device information corrected.
Event or Problem Description
N/a.

• Brand Name: EPIC¿ 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 #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: 17808132
• Report Number: 2135147-2023-04157
• Device Sequence Number: 7379804
• Product Code: LWR
• UDI-Device Identifier: 05415067033116
• UDI-Public: 05415067033116
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: UNK EPIC STENTED PORCINE HV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown