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MEDTRONIC IRELAND ENDURANT IIS BIFURCATED STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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| Model Number ESBF3614C103E |
| Device Problem
Leak/Splash (1354)
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| Patient Problems
Abdominal Pain (1685); Anemia (1706); Arrhythmia (1721); Weakness (2145); No Consequences Or Impact To Patient (2199); Injury (2348); Blood Loss (2597)
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| Event Date 02/01/2019 |
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Event Type
Injury
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Manufacturer Narrative
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Other relevant device(s) are: product id: etcf3636c49e, serial/lot #: (b)(4), ubd: 02-oct-2016, udi#: (b)(4); product id: etlw1613c93e, serial/lot #: (b)(4), ubd: 04-mar-2017, udi#: (b)(4); product id: etlw1613c82e, serial/lot #: (b)(4), ubd: 03-mar-2017, (b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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A heli-fx endoanchoring system and endurant stent graft system were implanted during the endovascular treatment of a 55mm thoracic aortic aneurysm.The proximal aortic neck diameter measured 30mm-36mm with a neck length of 5mm.It was reported approximately 4 years post the index procedure follow up ultrasound identified an undetermined endoleak.Per the investigator the cause of the event is unknown.No additional clinical sequelae were reported and the patient will be monitored.
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Manufacturer Narrative
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Additional information received reported that the patient attended a follow up visit where it was suspected that the patient has a type ia endoleak arising from either the proximal stent graft landing site at the left renal artery or at the left iliac limb.However the definite source of the endoleak could not be confirmed.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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Event Description
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It was reported that intervention was performed approximately five years post the index procedure and the endoleak was reported to be resolved.2 days post op the patient experienced cardiac arrhythmia and anemia/bleeding.Both events were assessed as related to the re-intervention procedure and the patient recovered with treatment.
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Manufacturer Narrative
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Event corrected.The intervention procedure was performed fours years post the index procedure not five years.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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Event Description
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It was reported that intervention was performed approximately four years post the index procedure.
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Manufacturer Narrative
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B:5 additional information received.It was reported that fourteen days post the intervention procedure, that treated the ia endoleak, the patient experienced bowel and abdominal pain along with neurological weakness in the left arm, an open thrombectomy was performed which reportedly did not resolve the event.Both events have been assessed as related to the reintervention procedure.During the intervention procedure an aortic cuff was implanted proximally to resolve the leak.The sponsors assessment of the type ia endoleak was unlikely related to the index procedure, not related to the endoanchors but possibly related to the disease under study.The anemia was assessed by the sponsor as having a possible relationship to the reintervention procedure.The cardiac arrhythmia was assessed by the sponsor as having a causal relationship to the reintervention procedure.A follow up ultrasound carried out just over a year post the intervention procedure showed a type ia endoleak.The patient has now c ompleted all required follow up for the trial and has exited the registry.H:6 updated.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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