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

Catalog Number UNK EPIC PLUS

Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907); Human-Device Interface Problem (2949); Separation Problem (4043)

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

Event Type  malfunction  

Event Description

It was reported that on unknown dates, there were multiple complaints regarding epic plus mitral valves being unstable on the valve holder.It was reported that the valve would wobble or tilt slightly while the surgeon was implanting sutures, which made it more difficult for the sutures to be placed correctly.Additionally, the valve holder button used to remove the top part of the holder can be easily pressed unintentionally as it is near the location where the valve is held and there is minimal force required to press the button.If the top part of the holder is detached unintentionally, it can be difficult to reattach it because it must be oriented a particular way, which can be difficult in the middle of a procedure.There have not been any negative patient impacts reported.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

The valve being unstable on the holder was reported.Field indicated that the valve would wobble or tilt slightly while implanting sutures, making it more difficult for the sutures to be placed correctly.Additionally, it was also reported that the valve holder button used can be easily pressed unintentionally as it is near the location where the valve is held and there is minimal force required to press the button.It was difficult to reattach the holder in the middle of procedure because a specific orientation of the handle is required.No patient harm was reported.A returned device assessment could not be performed as the device was not returned for analysis.The epic plus design validation report and epic plus design validation protocol were reviewed to ensure that each manufacturing and inspection operation was performed and the product met all customer requirement specifications, including stability when placing the valve and holder release mechanism.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.H6 medical device problem code: codes 1670, 2907, and 4043 removed.

Event Description

It was reported that on unknown dates, there were multiple complaints regarding epic plus mitral valves being unstable on the valve holder.It was reported that the valve would wobble or tilt slightly while the surgeon was implanting sutures, which made it more difficult for the sutures to be placed correctly.Additionally, the valve holder button used to remove the top part of the holder can be easily pressed unintentionally as it is near the location where the valve is held and there is minimal force required to press the button.If the top part of the holder is detached unintentionally, it can be difficult to reattach it because it must be oriented a particular way, which can be difficult in the middle of a procedure.The valve holder handle was also reported to be difficult to reattach if needed.There have not been any negative patient impacts reported.

Event Description

It was reported that on unknown dates, there were multiple complaints regarding epic plus mitral valves being unstable on the valve holder.It was reported that the valve would wobble or tilt slightly while the surgeon was implanting sutures, which made it more difficult for the sutures to be placed correctly.Additionally, the valve holder button used to remove the top part of the holder can be easily pressed unintentionally as it is near the location where the valve is held and there is minimal force required to press the button.If the top part of the holder is detached unintentionally, it can be difficult to reattach it because it must be oriented a particular way, which can be difficult in the middle of a procedure.The valve holder handle was also reported to be difficult to reattach if needed.There have not been any negative patient impacts reported.Subsequent to the previously filed report, additional information was received that the valves were not wobbling, but there was some looseness in the valve holder with the new edition of the epic plus valve compared to the epic valve.It was reported that there was no issue with the device itself but instead the training for the new edition was not sufficient.One instance included the physician requesting a rigid holder handle when one was not available but that there was no issue with the device.

Manufacturer Narrative

The valve being loose on the holder was reported.It was reported that there was no issue with the device itself but instead the training for the new edition was not sufficient.Field indicated that one instance included the physician requesting a rigid holder handle when one was not available but that there was no issue with the device.No patient harm was reported.A returned device assessment could not be performed as the device was not returned for analysis.The epic plus design validation report and epic plus design validation protocol were reviewed to ensure that each manufacturing and inspection operation was performed and the product met all customer requirement specifications, including stability when placing the valve and holder release mechanism.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: EPIC PLUS
• 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 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: 17720957
• MDR Text Key: 323092588
• Report Number: 2135147-2023-03921
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK EPIC PLUS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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