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Catalog Number FEM14120 |
Device Problem
Malposition of Device (2616)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that during a stent graft placement procedure, the stent deployment mechanism allegedly malfunctioned and missed the stenosis.It was further reported that the stenting was allegedly done in incorrect area.There was no reported patient injury.
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Event Description
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It was reported that during a stent graft placement procedure, the stent deployment mechanism allegedly malfunctioned and missed the stenosis.It was further reported that the stenting was allegedly done in incorrect area.There was no reported patient injury.
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Manufacturer Narrative
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H10: manufacturing review: as the lot number for the device was not provided, a review of the device history records could not be performed.Investigation summary: the stent delivery system was not returned for evaluation and photos were not provided which leads to inconclusive results.Based on the very limited information provided and as neither photos nor videos were provided for review, the investigation is closed with inconclusive results.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.The instruction for use state: 'if unusual resistance or high deployment force is encountered during stent graft deployment, abort the procedure, remove the delivery system and use an alternative device.' with regards to stent graft size selection, the instruction for use states "in order to ensure sufficient wall apposition, it is recommended to oversize the stent graft relative to the healthy (non-diseased) portion of the vessel".Holding and handling of the system during deployment was found sufficiently described.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Search Alerts/Recalls
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