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Catalog Number SPD2-US-060-320 |
Device Problems
Fracture (1260); Detachment of Device or Device Component (2907)
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Patient Problem
No Information (3190)
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Event Date 12/04/2019 |
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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Physician used a spider fx device during patient treatment.It is reported that the filter broke off during the procedure.A stent was placed to trap the free-floating filter.No patient injury reported.
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Manufacturer Narrative
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Additional information: physician used a spider fx during procedure to treat a chronic total occlusion (cto-100%) in the left sfa, popliteal and anterior tibial artery.It was reported that the left sfa was occluded.Decisio n was made to open the chronic total occlusion in the common femoral artery and anterior tibial artery.The sfa and popliteal were pre dilated and follwed by non medtronic drug-coated balloon.Non medtronic stents were implanted in the mid to distal sfa and popliteal.Visi pro stents were also implanted in the sfa.Thrombus burden was however, noted int he proximal sfa.Thrombectomy was carried out without much success.At this point there was the loss of filter in the sfa due to wire breakage.A short (6x40mm) stent was placed in the area of the filter.The filter was crushed between the two stents with complete rescue of the sfa.The thrombus in proximal sfa was treated with two balloon expandable stents (6x37mm and 7x59mm).Angio showed no residual stenosis.There was no further patient injury reported.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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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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