Model Number PED2-250-20 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Ischemia (1942); Transient Ischemic Attack (2109)
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Event Date 05/04/2019 |
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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Medtronic received a report that the patient experienced a post-op tia.The patient was undergoing surgery for treatment of an aneurysm.It was reported the index procedure was on 2019-05-03.The patient experienced a mild tia on (b)(6) 2019 through (b)(6) 2019.Ct perfusion showed ischemia/hypoperfusion changes over the left aca territory on (b)(6) 2019.Enxoaprin was given and repeated ctb.The relatedness was indicated as probable, and other risk factors were hypertension and hyperlipidemia.The patient recovered and the issue was resolved.There were no device issues indicated.
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Manufacturer Narrative
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This event is not reportable, as there is no device malfunction with the pipeline flex with shield.This device is not approved in the usa.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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Medtronic received a report that the patient experienced a post-op tia.The patient was undergoing surgery for treatment of an aneurysm.It was reported the index procedure was on (b)(6) 2019.The patient experienced a mild tia on (b)(6) 2019 through (b)(6) 2019.Ct perfusion showed ischemia/hypoperfusion changes over the left aca territory on (b)(6) 2019.Enxoaprin was given and repeated ctb.The relatedness was indicated as probable, and other risk factors were hypertension and hyperlipidemia.The patient recovered and the issue was resolved.There were no device issues indicated.The pipeline flex with shield was over the left a1 to the right a2 segment of the aca.The patient underwent treatment of an anterior communicating aneurysm.The aneurysm height was 4mm, width was 4.9x4.2mm.The neck was 3.3x2.8mmthe patient has a medical history of tia and moyamoya phenomenon.
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Event Description
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Additional informatoin received reported that a new hypodense infarct area was seen on the left frontal lobe through ct/brain perfusion studies performed on (b)(6) 2019.There were also ischemia/hypoperfusion changes over the left aca territory.
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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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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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Additional information received from the site reported new event of infarct, possibly related to procedure and possibly related to device.It was noted that there was a newly seen hypodense area over the high left frontal lobe over the middle/superior gyri, suggestive of infarct.The issue onset was (b)(6) 2019 with the patient status recovering/resolving and prasugrel given.
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Search Alerts/Recalls
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