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Model Number PED-500-25 |
Device Problems
Material Deformation (2976); Activation Failure (3270)
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Patient Problems
Muscle Weakness (1967); Visual Disturbances (2140); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
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Event Date 10/14/2021 |
Event Type
Death
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Event Description
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Medtronic received a report that the pipeline was kinked.The patient was undergoing surgery for treatment of a saccular, unruptured left internal carotid artery aneurysm.It was noted the p atient's vessel tortuosity was moderate.Medical history included hypertension, no known allergies, smoked for 30 years it was reported that the patient presented with bilateral ica aneurysms and elected for ped flow diversion.On (b)(6) 2021, the doctor gained access to left ica.Physician then used inifinity/navien 058/phenom 27 catheter combination to deliver the initial device (ped-500-25).Initial device covered the distal neck of the aneurysm but failed to cover the proximal end, with the distal end landing just proximal to the opthalmic artery.A second device (ped2-500-35) was then used to extend the initial construct and cover the neck in entirety, with the proximal end landing in the horizontal petrous segment.At conclusion of delivery, devices were deemed to be open & well opposed with sufficient neck coverage.Patient was prescribed brilinta & aspirin dapt.On (b)(6) 2021, the patient woke up with right sided weakness and eft gaze deviation.Ems brought patient to (b)(6) medical center in (b)(6)where cta showed left ica occlusion/potential stent thrombosis.No tpa issued as patient was outside window.Patient was then med flighted to (b)(6) for intervention.While in angio suite at (b)(6) for thrombectomy, patient was noted as having a kinked pipeline device that was relieved with balloon angioplasty.Post ballooning and thrombectomy, nchct showed evolving large infarct and further interventions were abandoned for fear of reperfusion injury.Patient is currently being held and monitored in nsicu for further management.The pipeline was not used for an indication that is not approved (off-label).The pipeline and any accessory devices were not prepared as indicated in the ifu.The sleeves were pre-deployed by the physician.Ancillary devices include an infinity sheath, navien intermediate guide catheter, and phenom 27 microcatheter.
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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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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 reported that the patient passed away from occlusion related complications.
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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 reported that while being treated for subsequent stroke, treating physician notes one of the devices may have been kinked.
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Search Alerts/Recalls
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