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

Model Number E100-27M-00

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2022, a 27mm epic valve was selected for procedure.It was noted during procedure that the valve holder disassembled when attempting to remove the valve holder from the epic valve while the valve was seated in the patient's annulus.It was noted that a small spring and other pieces fell onto the surgical field.The small spring and pieces were removed from the surgical field.The 27mm epic valve was successfully implanted and the procedure was completed without further complication.There were no adverse patient effects reported.The patient was recovering and neurologically stable at the time of report.

Manufacturer Narrative

An event valve holder broke apart during the procedure was reported.Information from the field indicated that there was no noted damage to the valve holder prior to use.The valve holder was returned to abbott and the investigation found the button and the spring had detached.Upon microscopic examination, marks of gripping were observed on already rotated spool.Signs of damage were noted at one of the front and both the rear buttons of valve holder.The golden plastic region of spool 's hexagonal cavity was dented.No anomalies or signs of damage were observed to the base portion of the holder assembly and to the plug.The cause of the detached and missing button could not be conclusively determined.How or when the damage occurred could not be conclusively determined; however, it is consistent with damage during implant procedure.The use of an alternate tool or forceful attempt to remove the valve holder away from the valve has the potential to create the marks seen in this reported incident.The pattern of the damage in the hexagonal cavity of the holder was consistent with alternative and sharp tool which may have been used at the time of implant to remove the holder from the valve or the holder handle from the holder.It is unlikely that performing three cuts to remove the seated valve from the holder would lead to the release button disassembling.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications at the time of commercialization, which includes inspection of the holder and inspection of the final valve assembly.H6 health effect - clinical code: 4580 code removed.H6 health effect - impact code: 4648 code removed.

Event Description

It was reported that on 19 october 2022, a 27mm epic valve was selected for procedure.It was noted during procedure that the valve holder disassembled when attempting to remove the valve holder from the epic valve while the valve was seated in the patient's annulus.It was noted that a small spring and other pieces fell onto the surgical field.The small spring and pieces were removed from the surgical field.The 27mm epic valve was successfully implanted and the procedure was completed without further complication.There were no adverse patient effects reported.The patient was recovering and neurologically stable at the time of report.Subsequent to the previously filed report, additional information was received that the holder broke apart while seating the valve.The pieces of the valve holder that disassembled fell into the heart of the patient and had to be carefully found and removed.The 27mm epic valve and valve holder were not mishandled or damaged during device preparation.There was no noted damage to the valve holder prior to use.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects reported.There was no initial or prolonged hospitalization due to this event.It is unknown what cause the valve holder to disassemble.

• Brand Name: EPIC STENTED PORCINE HEART VALVE
• 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 #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: 15737344
• MDR Text Key: 307510527
• Report Number: 2135147-2022-01943
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734055574
• UDI-Public: 05414734055574
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E100-27M-00
• Device Catalogue Number: E100-27M-00
• Device Lot Number: BR00026813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2020
• 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