Catalog Number 1012014-150 |
Device Problems
Mechanical Jam (2983); Activation Failure (3270)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/28/2022 |
Event Type
malfunction
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Event Description
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It was reported that the procedure was to treat a lesion located in the superficial femoral artery.The absolute pro ll/5.0/150mm on 135cm ce thumbwheel jammed and the stent completely failed to deploy.The device was removed without issue.There was no reported adverse patient effect and no clinically significant delay in the procedure.Another absolute pro ll was used to complete the procedure.No additional information was provided.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.
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Manufacturer Narrative
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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.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.
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Manufacturer Narrative
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The device was not returned for analysis.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 did not indicate a lot specific quality issue.It is possible that the distal shaft was bent in the anatomy and/or interaction with other devices resulted in preventing the shaft lumens from moving freely resulting in the reported mechanical jam and the reported activation/deployment failure; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.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.D9: device is not available for evaluation.
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Manufacturer Narrative
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The device was returned for analysis.The reported activation failure was able to be confirmed.The reported mechanical jam was unable to be replicated in a testing environment due to the condition of the returned device.Additionally, chatter marks were noted on the device and the sheath was noted to be wrinkled.It is possible that the distal shaft was bent in the anatomy resulting in the noted repeating indentations (chatter marks) noted on the entire length of the sheath and the noted wrinkled sheath preventing the shaft lumens from moving freely resulting in the reported mechanical jam and the reported activation/deployment failure; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.Manipulation of the device/repeated rotation of the thumbwheel likely resulted in the noted device damages (gap between the handle halves, smashed proximal spool axle).D9, h3 - device available for evaluation
h6- type of investigation code 4114 removed.
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Search Alerts/Recalls
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