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Model Number RONYX30030UX |
Device Problems
Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Chest Pain (1776); Dyspnea (1816); Myocardial Infarction (1969); Nausea (1970); Dizziness (2194); Anxiety (2328)
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Event Date 02/06/2023 |
Event Type
Injury
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Event Description
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A patient had four resolute onyx coronary drug eluting stents implanted on (b)(6) 2022.This procedure was performed for chronic total occlusion (cto) of the right coronary artery (rca).The vessel had been stented from the ostium to the distal segment at the bifurcation of the right posterior descending artery (rpda) and posterolateral artery (pla).The 2.5 x 38mm resolute onyx stent was inflated to 14 atm, the 3.0 x 38mm resolute onyx stent was inflated to 12 atm, the 3.0 x 30mm resolute onyx stent was inflated to 15 atm, and the 2.25 x 26mm resolute onyx stent was inflated to 10 atm followed by the balloon at 24 atm.A 3.0 x 30mm non-medtronic (mdt) balloon was used for post-dilation up to 22 atm as well as a 2 x 15mm balloon up to 10 atm.All stent balloons successfully deflated post stent dilation.There were no difficulties noted during the removal of the guidewire.The balloon or the delivery system did not snag on the deployed stents.There were no difficulties during stent deployment and there were no complications.Approximately 11 months later it was reported that the patient experienced, and showed signs of what was thought to be another heart attack and attended the ed (emergency department).The previously implanted device caused another heart attack.It was discovered through imaging that one of the resolute onyx stents had fractured.A recent coronary angiogram was performed for unstable angina demonstrating severe 90% in-stent restenosis (isr) of the distal segment of the rca with possible stent fracture.The ostial/proximal previously implanted stent appears under-expanded with mild-moderate isr.The focal mid-segment appears under-expanded and there is focal isr in the distal segment near a hinge point with suspected stent fracture.There was timi grade 3 flow across the lesion.The patient went for a follow-up percutaneous interventional procedure during which the fractured stent was ballooned, and a non-medtronic stent was implanted inside the fractured stent to open the blockage.It was detailed that right common femoral artery access was obtained using fluoroscopic and ultrasound guidance.First in the distal rca, balloon angioplasty was performed with a 2.5 x 20 non-mdt nc balloon.The balloon was placed across the lesion and given a single inflation with a maximum inflation pressure of 20 atm.The balloon expanded well.Using a non-mdt intravascular ultrasound (ivus), stent fracture could not be identified definitively.The resolution of the ivus system was insufficient to determine the mode of stent failure and isr.Optical coherence tomography (oct) and high definition (hd) ivus was not available.After balloon expansion a non-mdt guide extension catheter was used to help place and deploy a 3.5 x 24mm non-mdt stent.The stent was deployed with a single prolonged inflation and a maximum pressure of 11 atm.Ivus was repeated,and the stent diameter was 2.5mm, under-expanded.Balloon angioplasty with a 3.0 x 15mm non-mdt balloon was performed across the lesion, with a single inflation of a maximum 18 atm inflation pressure.Again, balloon angioplasty was performed across the lesion with a 3.5 x 20mm non-mdt balloon, given four inflations with a maximum inflation pressure of 22 atm.The stent was post-dilated up to 22 atm.Following intervention, there was 0% residual stenosis and timi grade 3 flow (brisk flow).There was no dissection.For the previously implanted stent the areas of under expansion in the mid and ostial-proximal vessel were also ballooned using a 3.5mm nc balloon at 22 atm.Finally, the ostial/proximal and mid segments were balloon using a 4.0mm nc balloon to 18 atm, including flaring the ostium.There was also noted to be 50% stenosis in the proximal rca with timi grade 3 flow across the lesion.Balloon angioplasty was performed with a 4.0 x 15mm non-mdr nc balloon.The balloon was given five inflations up to a maximum pressure of 18 atm.Following intervention, there was 0% residual stenosis and timi grade 3 flow (brisk flow).There was no dissection.No further patient injury was reported.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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Additional information: during the index procedure, the lesion was crossed in an antegrade approach.A non-medtronic (mdt) balloon was used with a double blind stick and swap technique with a 20 and 200 non-mdt guidewires, to successfully enter the distal true lumen.The lesion was ballooned restoring timi 3 flow, but there was poor flow distally that was at the bifurcation of the pda and posterolateral vessel (plv).Three of the resolute onyx drug eluting stents were used from the distal rca all the way to the ostium, but there remained poor flow.A non-mdt dual lumen microcatheter and reversed guidewire technique were used to wire into the right posterolateral.A kissing balloon inflation with 2.0 mm balloons was performed.With intravascular ultrasound (ivus), it demonstrated there was disease into the pda and the distal rca, so this was covered with an additional 2.25 x 26 mm resolute onyx stent, that was post dilated proximal to the bifurcation with a 3.0 mm balloon.In the end, there was excellent final result with timi 3 flow into the pda as well as the right posterolateral branch.Annex d code.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional information: using a non-mdt ivus and cineangiography, stent fracture could not be identified definitively.The ostial/proximal and mid rca previously implanted stents appeared under-expanded.A launcher guide catheter was used during the procedure.It was later reported that the patient is dealing with new cardiac issues that are being addressed.Annex a e codes.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional information: it was later reported that the patient has been to the emergency room several times and has had two more catheterizations.The first in (b)(6) 2023 where laser intervention was used in an attempt to open the occlusion caused by the fractured stent.The second intervention was in (b)(6) 2024 where it was discovered that the full length of the artery containing the medtronic fractured stent is completely occluded, filled with scar tissue, and no longer able to be opened.It appears the scar tissue was generated by the multiple procedures attempting to re-open the artery with the fractured stent occlusion.It was indicated that the damaged artery and associated symptoms is permanent.The patient is constantly experiencing chest pain with episodes of nausea, dizziness, and labouring loss of breath.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: it was further reported that the last procedure was only an exploratory procedure as intervention was not possible.The patient has stopped physical and psychological treatment.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: it was later reported that the patient was recently in hospital and had another heart attack and another stent.A total of 10 stents have been implanted.The patient took a long time to recover.Correction: annex e code.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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