Catalog Number 1012015-150 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Mechanical Jam (2983); Activation Failure (3270)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/18/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.Na.
|
|
Event Description
|
It was reported that the procedure was performed to treat a lesion in the superficial femoral artery.A 6x150mm absolute pro ll self-expanding stent system (sess) was advanced with a non-abbott guiding catheter and an unspecified.018 guide wire.During deployment, the thumbwheel was fine at first but then failed to turn, and the stent could only partially deploy.The stent was able to be removed, and an unspecified absolute pro ll was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
|
|
Manufacturer Narrative
|
H6: device code 2017- failure to follow steps / instructions.Visual, dimensional and functional analysis was performed on the returned device.The reported deployment issue was unable to be confirmed due to the condition of the returned unit as the stent was not returned and had been fully deployed from the device.The resistance with the thumbwheel was confirmed due to the noted separation of the outer member in the handle preventing further rotation of the thumbwheel.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history revealed no other incidents and/or complaints reported from this lot.It should be noted that the absolute pro ll peripheral self-expanding stent system utilizes a 0.035¿ (0.89 mm) guide wire as indicated on the product label and in the instruction for use (ifu).Additionally, the absolute pro ll instruction for use states: ¿use of an undersized guide wire, with insufficient support, may cause kinking in the stent delivery system.¿ the investigation determined that the reported difficulties were likely the result of using an undersized guidewire with the absolute pro ll device.It is likely that inadequate support for the shaft due to use of an undersized guidewire caused restriction to the distal shaft lumens in the anatomy (possibly over the aortic bifurcation), preventing movement of the shaft lumens and causing the thumbwheel to lock up resulting in partial deployment.Additional attempts to rotate the thumbwheel against resistance likely caused the outer member separation at the distal end of the shuttle preventing any further transmission between the thumbwheel and retractable sheath.In addition, with the outer member separated within the handle, this likely allowed slack in the ribbon causing the ribbon to entangle outside of the thumbwheel resulting in the handle halves to slightly separate.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
|
|
Event Description
|
It was reported that a 6x150mm absolute pro ll self-expanding stent system (sess) was advanced with a non-abbott guiding catheter, and the stent could only partially deploy.The stent was removed.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was received: the procedure was performed to treat a lesion in the superficial femoral artery with an unspecified.018 guide wire.During deployment of the 6x150mm absolute pro ll self-expanding stent, the thumbwheel was fine at first but then failed to turn.An unspecified absolute pro ll was used to successfully complete the procedure.No additional information was provided.
|
|
Manufacturer Narrative
|
Visual, dimensional and functional analysis was performed on the returned device.The reported deployment issue was unable to be confirmed due to the condition of the returned unit as the stent was not returned and had been fully deployed from the device.The resistance with the thumbwheel was confirmed due to the noted separation of the outer member in the handle preventing further rotation of the thumbwheel.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history revealed no other incidents and/or complaints reported from this lot.It should be noted that the absolute pro ll peripheral self-expanding stent system utilizes a 0.035¿ (0.89 mm) guide wire as indicated on the product label and in the instruction for use (ifu).Additionally, the absolute pro ll instruction for use states: ¿use of an undersized guide wire, with insufficient support, may cause kinking in the stent delivery system.¿ the investigation determined that the reported difficulties were likely the result of using an undersized guidewire with the absolute pro ll device.It is likely that inadequate support for the shaft due to use of an undersized guidewire caused restriction to the distal shaft lumens in the anatomy (possibly over the aortic bifurcation), preventing movement of the shaft lumens and causing the thumbwheel to lock up resulting in partial deployment.Additional attempts to rotate the thumbwheel against resistance likely caused the outer member separation at the distal end of the shuttle preventing any further transmission between the thumbwheel and retractable sheath.In addition, with the outer member separated within the handle, this likely allowed slack in the ribbon causing the ribbon to entangle outside of the thumbwheel resulting in the handle halves to slightly separate.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Although the difficulties encountered appear to be related to procedural circumstances, on may 11th, 2022, abbott determined that a field safety notice (fsn) was required for the absolute pro ll peripheral self-expanding stent system (psess).Abbott has confirmed reports of mechanical locking, stent deployment and partial stent deployment failures, resulting from unintended excessive force used to deploy the stent.To reduce occurrences of deployment failures and associated outcomes, abbott is notifying all users of the potential causes and risks.
|
|
Event Description
|
Subsequent to the original filing, on may 11th, 2022, abbott determined that a field safety notice was required for the absolute pro ll peripheral self-expanding stent system (psess).Abbott has confirmed reports of mechanical locking, stent deployment and partial stent deployment failures, resulting from unintended excessive force used to deploy the stent.To reduce occurrences of deployment failures and associated outcomes, abbott is notifying all users of the potential causes and risks.
|
|
Search Alerts/Recalls
|
|