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Catalog Number RONYX30018UX |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Myocardial Infarction (1969); Occlusion (1984); Thrombus (2101); Injury (2348); Vascular Dissection (3160)
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Event Date 08/06/2020 |
Event Type
Injury
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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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Event Description
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During a procedure, one resolute onyx rx coronary drug eluting stent was implanted to treat a mildly tortuous, mildly calcified lesion exhibiting 95% stenosis located in the mid circumflex (cx) artery.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Excessive force was not used during delivery.It was reported that acute stent thrombosis occurred in the mid cx artery.It was stated that a stemi and a proximal edge dissection also occurred and the vessel was completely shut down.It was stated that the culprit lesion was in the left anterior descending artery (lad).The patient went for open heart surgery and 2 grafts were implanted into the lad and diagonal branch.The patient was reported to be alive with injury.
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Manufacturer Narrative
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Additional information: it was stated that the thrombus occurred within the newly deployed ronyx30018ux stent.The thrombus reportedly occurred almost immediately after stent deployment.The thrombus was treated pharmacologically and with aspiration.The vessel was observed on ivus to have completely shut down post deployment and post dilation of the ronyx30018ux stent using a 3.25mmnc euphora and a 3.5mm nc euphora balloon.The mi was treated with a ronyx30018ux aspiration and post dilation with a 3.25mm nc euphora balloon and a 3.5mm nc euphora balloon.An export ap aspiration catheter, a 3.25mm nc euphora and a 3.5mm nc euphora balloon were used.It was later stated that the stent seemed expanded but a proximal edge dissection was then suspected.A dose of integrin followed approximately 11 minutes later by a second therapeutic dose of integrin was administered to achieve an act of 180s.Was discharged three days later.It was later reported that a dissection did not occur as a result of the procedure.It was mentioned that there was difficulty experienced achieving therapeutic act at the beginning of stemi presentation, however, the physician does not entirely blame stent for this.It was stated that a possible cause for vessel shut down was the proximal circ ¿ lad untreated culprit lesion, thus the reason patient was sent to cabg correction: adverse event selected in b1 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: it was stated that this hyperacute stent thrombosis event occurred despite adequate anticoagulation, antiplatelet therapy, adequate stent expansion/apposition on ivus, and good vessel inflow and outflow.It was stated that it was thought the case was finished and final pictures were taken and then fresh thrombus was noticed within the stent.It was noted that the stent thrombosis was recurrent even on integrilin.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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Search Alerts/Recalls
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