Catalog Number RONYX30022UX |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Patient Problem/Medical Problem (2688)
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Event Date 02/26/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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A resolute onyx rx drug eluting stent was used to treat mildly calcified and tortuous proximal lad lesion exhibiting 60% stenosis.No damage noted to device packaging and no issues removing the device from the hoop/tray.The device was inspected and negative prep performed with no issues noted.The lesion was pre-dilated.The device did not pass through a previously deployed stent.No resistance was encountered while advancing the device and no excessive force used.It was reported that there was a loop in the distal end of the non medtronic wire.The wire was pulled hard and part of the wire broke off, and got caught in the lad/diag.When snaring the broken wire, the proximal of deployed resolute onyx stent got snared, and was pulled out of patient.The proximal vessel was then re-stented.No patient injury reported.The patient is reported to be fine.
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Manufacturer Narrative
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Image review: the returned procedural images capture the patient lesion condition as reported by the account.The pre-dilation of the target lesion is captured in the images.An unknown stent is delivered and implanted in the lad.Post dilation of the implanted stent is also captured.A second stent is successfully delivered and implanted to a diagonal branch of the lad.The complaint device is then delivered and implanted proximal to the previously implanted stents.Attempts to remove the non-medtronic guidewire are captured, however resistance is encountered due to interaction between the guidewire and complaint resolute onyx device.A detached distal portion of the guidewire is visible in the images, the guidewire is caught in the complaint device.Attempts to remove the detached guidewire results in the movement of the complaint device from the patient.A lesion is then stented with an unknown stent in the original location of the complaint stent.Improved flow is visible post procedure.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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