LUTONIX, INC LUTONIX 035AV DRUG COATED PTA DILATION CATHETER; DRUG COATED BALLOON PTA CATHETER
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Model Number 9010 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Restenosis (4576)
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Event Date 12/21/2022 |
Event Type
Injury
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Event Description
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It was reported through results of a clinical trial that ten months and four days post index procedure using a drug coated balloon catheter, the subject had serious adverse event of recurrent stenosis.The adverse event relationship was possibly related to study device, possibly related to procedure, and definitely related to av access circuit which required additional surgical intervention.It was further reported that ten months and twenty-four days post index procedure, the target lesion had maximum initial recurrent stenosis of sixty-two percent.Other drug coated balloon catheter was used for treatment.The re-intervention was successful, and the patient recovered with final residual stenosis of fifty percent.However, the current status of the patient is unknown.
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Manufacturer Narrative
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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.(expiration date: 03/2022).Device not returned.
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Search Alerts/Recalls
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