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Model Number RONYX20012UX |
Device Problems
Entrapment of Device (1212); Device Dislodged or Dislocated (2923); Positioning Problem (3009)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/12/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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An attempt was made to use one resolute onyx coronary drug eluting stent to treat a lesion.Negative prep was performed with no issues.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.It was reported that the device failed to cross the lesion.When the stent was pulled back through the catheter, the stent unknowingly came off the balloon.Then, when an attempt was made to go up the catheter with a new different stent, this stent ended up tangling with the dislodged resolute onyx stent left in the catheter.The issue was spotted prior to deployment and both stents were removed safely from the patient.The patient is alive with no injury.
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Manufacturer Narrative
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Additional information: the lesion was heavily tortuous and heavily calcified, with 90% stenosis located in the obtuse marginal (om) artery.Excessive force was not used during delivery.The stent being inserted to which the resolute onyx became entangled was a non-medtronic device.The resolute onyx stent got stuck in a non-medtronic hemostasis valve as it was being removed from the catheter.Resistance was noted during withdrawal, and excessive force was not used.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Manufacturer Narrative
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Additional information: the catheter used during the procedure was an ebu shaped device.The stent got stuck on a balloon wire but was safetly removed through the catheter with no other intervention required.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Manufacturer Narrative
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Additional information: annex d codes.Correction: resistance was not noted during withdrawal of the device.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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