MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC PLUS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number	600315422
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2024, a 27mm epic plus mitral valve was chosen for mitral valve replacement.However, during implant, holder handle was unstable (wobbling).In addition, the release button on the valve holder was accidentally pressed, and the device was separated.The physician attempted to attach the holder and the device again, but it was not successful.The device has been successfully implanted using ratchet mechanism of the device, and result of cardiac scintigraphy indicated no issues.However, the physician commented it was very stressful experience since the holder handle and the device were unstable (wobbling).There were no adverse patient consequences.The patient condition is stable.The red circle in the attached photo is unstable/wobbling part.
Additional Manufacturer Narrative
An event of holder handle was unstable and unable to attach the valve holder to the handle could not be confirmed.The investigation confirmed the device met functional and visual specifications when analyzed at abbott.The holder was securely connected to the test holder handle e-2000 and passed the fuctional testing.Little flaring was observed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event could not be conclusively determined; however, abbott is continuing to monitor this issue.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: EPIC PLUS
• 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: 20056916
• Report Number: 2135147-2024-04140
• Device Sequence Number: 12671313
• Product Code: LWR
• UDI-Device Identifier: 05415067033062
• UDI-Public: 05415067033062
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 600315422
• Device Lot Number: BR00043641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2024
• 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 Sex: Unknown