It was reported that during a stent graft placement procedure in distal end of the right external iliac, the device was allegedly unable to cross the lesion, even after shockwave had been used.The device was pushed beyond the lesion outside of the sheath.It was further reported that the stent had allegedly moved from retrograde or proximal to lesion location just by about ten millimeter.The procedure was completed using another device.There was no reported patient injury.
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H10: as the lot number for the device was provided, a review of the device history records will 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.H10: d4 (expiration date: 06/2025) 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.H3 other text : device not returned.
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