Catalog Number 9-AVP2-012 |
Device Problem
Difficult to Fold, Unfold or Collapse (1254)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/22/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that on (b)(6) 2023, a 12mm amplatzer vascular plug ii was chosen for treatment of an endo leak in a transcatheter aortic valve implantation (tavi) case.During preparation, the device was properly prepared per instructions for use (ifu).During procedure, it was noted that the device didn't open.The device was removed form the patient prior to release.The procedure was terminated.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported recovering.
|
|
Manufacturer Narrative
|
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
|
|
Manufacturer Narrative
|
An event of device deformity was reported.The investigation confirmed the device met functional and visual specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.It was noted that an unknown size delivery system was used which could have contributed to the reported event.However, it could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
|
|
Search Alerts/Recalls
|