|
Model Number RONYX30018UX |
Device Problems
Fracture (1260); Material Deformation (2976)
|
Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/07/2024 |
Event Type
Injury
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
An attempt was made to use one resolute onyx coronary drug eluting stent to treat a moderately tortuous, severely calcified lesion with 100% chronic total occlusion in the proximal/ostium left main (lm) coronary artery /left anterior descending (lad) artery.It was reported that stent deformation occurred in vivo during post deployment.The causative device was a post dilation balloon.A stent fracture was reported to have occurred.The patient is alive with no injury.
|
|
Manufacturer Narrative
|
Product analysis: the device was returned for analysis.Kinks were evident along the hypo-tube.The delivery system returned with the balloon in a post inflated state.The stent was not returned.The reported failures could not be confirmed from analysis of the returned delivery system.No other damaged evident to the remainder of the device.Additional information: the lesion was pre-dilated.Resistance was noted while advancing the device to the lesion.The device did not pass through a previously deployed stent.The post-dilation balloon was another balloon, and was not the stent delivery system balloon.The stent fracture was treated by implanting stent over stent.The patient is alive with no further injury.Event date provided.Gender provided.Lot number updated updates to sections: b.Adverse event or product.B.2.Outcome attributed to adverse event.H.1.Type of reportable event.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.
|
|
Manufacturer Narrative
|
Additional information: there were no issues noted with the other stent used to treat the stent fracture.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.
|
|
Manufacturer Narrative
|
Additional information: it was later reported that the target lesion was in right coronary artery.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.
|
|
Manufacturer Narrative
|
Product analysis: the fluoroscopic images provided show the treatment of an ostial proximal lesion of the rca.The ostial lesion was stenotic.Multiple pre-dilations were completed, and the stenosis was not resolved.This was followed by delivery and deployment of a long stent that was deployed overlapping with the previously deployed stents.The proximal end of the stent was further post dilated on numerous occasions followed by delivery and deployment of a shorter proximal stent.Fluoroscopic images with and without contrast injections failed to show stent deformation or fracture.Subsequent still images taken from the fluoroscopic images provided show evidence of stent deformation, but the cause of the deformation is unknown.Two still fluoroscopic images received where it shows the newly deployed resolute onyx stent in the proximal rca.Due to the angulation at which the post deployment stent is accessing the vessel it appears that wire bias has contributed to previous adjacent stent wires separating as they experienced the force of attempting to deliver the balloon.There possibility exists that the final post dilation balloon and procedural wire may have caught on the newly deployed stent due to the curvature of the stent/vessel.Or the possibility exists that the tip of the guide catheter may have caught on the stent resulting in the damage.The reports of a fracture cannot be confirmed but it is expected that the apparent fracture is more likely separation of the previously adjacent unwelded stent wires and that the stent weld or wire has not fractured.But this cannot be confirmed from the images provided.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.
|
|
Search Alerts/Recalls
|
|
|