Model Number AGFN-756 |
Device Problems
Material Frayed (1262); Shipping Damage or Problem (1570)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/18/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that on (b)(6) 2023, a 21mm sjm regent mechanical heart valve (flexcuff), was selected for an implant.The surgeon removed the valve from the operating room warehouse, opened the package and found that the valve ring was partially damaged.The physician did not want to waste the valve and thought that implantation would not affect the performance of the valve.The physician attempted implanting it in the patient but removed it due to difficulty suturing.A new non-abbott valve was used to complete the procedure.The product box containing the device was also noted to have been damaged.The patient is stable.
|
|
Manufacturer Narrative
|
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
|
|
Manufacturer Narrative
|
The reported event of damaged packaging and device damage was reported.The investigation confirmed that the sewing cuff was torn/frayed and contained blood.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Image from the field appeared to show the sweing cuff.Based on the information received and returned device analysis, the reported damaged packaging and device damage could not be conclusively determined.However, incident is consistent with damage during use.
|
|
Search Alerts/Recalls
|