Catalog Number PXP35-06-57-080 |
Device Problems
Difficult to Remove (1528); Material Deformation (2976); Positioning Problem (3009)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/04/2024 |
Event Type
malfunction
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Event Description
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Physician attempted to use a visipro balloon expandable stent during treatment of a plaque lesion in a patient.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging (i.E.Shelf carton, hoop tray).There were no issues noted when removing the device from the hoop/tray.The device was prepped per ifu with no issues identified.Embolic protection was not used.The device did not pass through a previously-deployed stent.No resistance was encountered when advancing the device.It was reported the stent was unable to cross a stenosis in front of target lesion.Physician decided to pull back the stent into the sheath to remove it.It was not possible to pull back the stent into the sheath because the stent struts were in the way and blocked it.The stent never was inflated.Using excessive force and damaging the stent it was possible to pull the stent back into the she ath.A replacement medtronic device was used to complete procedure.No patient injury reported.
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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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Manufacturer Narrative
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Product analysis the device was returned loaded in a 6fr sheath.The returned stent was confirmed to be 57mm.A visual inspection found that the proximal struts were damaged the device could not be retracted out of the sheath due to the damage on the proximal end of the stent 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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