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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER
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| Model Number PED2-275-12 |
| Device Problems
Structural Problem (2506); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
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| Patient Problems
Vasoconstriction (2126); Unspecified Nervous System Problem (4426); Thrombosis/Thrombus (4440)
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| Event Date 01/12/2023 |
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Event Type
Injury
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Event Description
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Medtronic received information that a patient treated with two ped3 pipelines had complications.Thrombus formation on device intraprocedurally, vasospasm, and post-procedure neurologic decline requiring emergent repeat dsa.Neuro decline and intra-stent thrombus formation in the context of subarachnoid hemorrhage due to brain aneurysm rupture and vasospasm.The events were possibly related to the pipelines and had a casual relationship to the procedure.Probable relationship to the antiplatelet therapy.The events are not resolved.
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Manufacturer Narrative
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Event related to regulatory report #: 2029214-2023-00088.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 was received that thrombus event was found on device intra-procedurally.The subject had post procedure neurological decline requiring emergent dsa.Dsa showed no evidence of thromboembolic complication.No other interventions or treatments were performed in relation to the complication.The event was recovering/resolving.The site assessed the event as possible related to the antiplatelet therapy.Additionally, the event "vasospasm" was updated to cerebral vasospasm.The subject had severe cerebral vasospasms post-procedure and was treated with intra-atrial infusions x8.The patient is no longer receiving infusions and is stable.The event did not result in hospitalization but was treated with percutaneous intervention.
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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 was received that the thrombus was recovered/resolved on (b)(6) 2023 and the cerebral vasospasm was recovered/resolved on (b)(6) 2023.The events required medical intervention.
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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 non-occlusive in-stent thrombosis intra-procedurally.
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Event Description
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Additional information was received that the patient recovered and was discharged.The patient experienced generalized physical deconditioning related to vasospasm.Transitory in-stent thrombosis disappeared spontaneously without harm to the patient.The patient underwent several therapeutic angio/dsa for intra-arterial treatment until the vasospasm resolved.The intra-stent thrombus resolved spontaneously.No evidence of it was found in the emergent dsa, only vasospasm.The neurological decline as per mrs 2 at discharge was attributed to generalized physical deconditioning secondary to vasospasm/underlying disease.No focalized neuro-deficit was reported.The cause of neurological decline was generalized physical deconditioning secondary to vasospasm.Neuro-decline was not related to the transitory in-stent thrombosis which resolved spontaneously, without additional treatment or intervention.
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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 submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Additional information was received that the event resulted in a prolongation of existing hospitalization.There was a decline in mrs.
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Event Description
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Additional information was received reporting multiple pipeline devices were not being used when the movement occurred and this incidence occurred during the first pipeline implantation.Once the wire was recaptured, as planned the second pipeline device was implanted.Per rdc, the pipeline was implanted.The site did not report any stent damage.The following procedure notes were reported.Per procedure notes, ¿the 5/6 fr short sheath was exchanged for a 6/7 short sheath over a microwire.The sheath was flushed and repeat radial angiography demonstrated satisfactory vessel caliber, collateral flow, and no evidence of puncture site complication.A bmx-81 guide catheter over a 5-fr simmons-2 select catheter was then advanced into the aortic arch, reformatted, and the left common and left internal carotid arteries were selectively catheterized.A new cerebral roadmap was obtained.The remaining procedure was performed under continuous biplane fluoroscopy and roadmap conditions.A phenom plus intermediate catheter over a phenom-27 microcatheter and aristotle 024 microwire were then advanced into the intracranial circulation.The microcatheter and microwire were advanced into the left ml segment and the phenom plus was advanced into the distal cavernous ica, and the microwire was removed.Hcp then selec ted a pipeline shield 2.5 x 12 mm device, prepared this appropriately, and advanced this through the phenom-27 delivery microcatheter.Using a combination of unsheathing and device loading, the ptfe sleeves were flipped and the device was deployed from the distal supraclinoid ica and across the neck of the aneurysm.Multiple acquisitions were made during this process to ensure appropriate device delivery.There appeared to be a less than 3 mm landing zone of device coverage proximal to the aneurysm.Hcp then attempted to cross the device and recapture the delivery wire.In doing so, the proximal end of the stentwas bumped resulting in shortening of the stent.The wire was ultimately recaptured successfully and removed while leaving the phenom-27 in the left ml segment.Repeat angiography from the guide catheter demonstrated a less than 1 mm area of residual aneurysm neck not covered by the device, and partial coverage of the left al origin by the distal device.There was satisfactory wall apposition of the device, and no evidence of thromboembolic complication.Hcp then selected a pipeline shield 2.75 x 12 mm device, as previously planned, prepared this appropriately, and advanced this through the phenom-27 delivery microcatheter.Using a combination of unsheathing and device loading, the ptfe sleeves were flipped and the device was deployed within the previous device in telescoping fashion.The distal landing point was just proximal to the distal end of the prior stent, and the proximal landing zone was just distal to the ophthalmic artery origin.Multiple acquisitions were made during this process to ensure appropriate device delivery.Repeat angiography from the guide catheter demonstrated satisfactory placement of the second device, with over 3 mm of aneurysm neck coverage both proximally and distally.There was satisfactory wall apposition at all points.The delivery wire was then recaptured by bringing the phenom-27 though the construct without difficulty, and the wire and phenom-27 were removed.
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Manufacturer Narrative
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Codes updated to reflect new information.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 was received reporting medications nitroglycerin start date (b)(6)2023 dose 100ug qd end date (b)(6) 2023.Nitroglycerin start date (b)(6) 2023 dose 50ug once end date (b)(6) 2023.Verapamil start date (b)(6) 2023 dose 20mh once end date (b)(6) 2023.Verapamil start date (b)(6) 2023 dose 20mg qod end date (b)(6) 2023.Verapamil start date (b)(6) 2023 dose 40mg qod end date (b)(6) 2023.Additional information was received reporting shortening of the stent.When attempted to cross the device and recapture the delivery wire, in doing so the proximal end of the stent was bumped off resulting in the shortening of the stent.The wire ultimately recaptured successfully and removed.The related device was ped2-275-12, lot b331434.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Additional information received reported suspected thrombus formation on device.Due to patient neuro decline, a second dsa was performed.Dsa showed no evidence of thromboembolic complications.
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