Catalog Number 9-PFO-025 |
Device Problem
Difficult to Fold, Unfold or Collapse (1254)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/24/2023 |
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 a 25mm amplatzer pfo occluder was selected for implant on (b)(6) 2023 using a 8f amplatzer trevisio intravascular delivery system.During implant the right atrial disc took on a bowl shape.The device was removed from the patient and prepared in a bowl, in which the right atrial disc took on a bowl shape again.There were no interactions with cardiac structures during deployment.There were no angulation or kinks noticed in the delivery system.The patient remained hemodynamically stable throughout the procedure.There were no adverse effects.There was no clinically significant delays in the procedure.
|
|
Event Description
|
N/a.
|
|
Manufacturer Narrative
|
An event of device deformity could not be confirmed.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There were no complaints associated with any other devices from the lot.The cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
|
|
Search Alerts/Recalls
|