| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Stroke/CVA (1770); Dizziness (2194); Stenosis (2263); Obstruction/Occlusion (2422); Vascular Dissection (3160); Thrombosis/Thrombus (4440); Insufficient Information (4580)
|
| Event Date 10/24/2014 |
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
Wiebke kurre 1, marta aguilar-pérez, sebastian fischer, guy arnold, elisabeth schmid, hansjörg bäzner, hans henkes."solving the issue of restenosis after stenting of intracranial stenoses: experience with two thin-strut drug-eluting stents (des)¿taxus element¿ and resolute integrity¿".Cardiovascular and interventional radiology, no.3, 2015, http://doi.Org/10.1007/s00270-014-1001-3.Pmid: 25342135.Pages: 583-91.A2: average age a3: majority gender b3: date of publication patient deaths were also included in the results of the journal article, however no causal link suggesting that the medtronic devices used in the patient cohort may have caused or contributed to the deaths was provided.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.
|
| |
|
Event Description
|
|
A journal article was submitted for review titled "solving the issue of restenosis after stenting of intracranial stenoses: experience with two thin-strut drug-eluting stents (des)¿taxus element¿ and resolute integrity¿." the purpose of this retrospective study was to report on the experience of using two new-generation drug eluting stents (des) for the treatment of intracranial atherosclerotic disease.A total of 101 consecutive patients with 117 atherosclerotic stenoses were treated with either a non-medtronic des (n=71 stenoses) or the medtronic resolute integrity des (n=42 stenoses) in 112 procedures.Indication for treatment included stroke related to the stenosis in 48 and transient ischemic attack (tia) in 30 lesions.Indication for treatment of patients without ischemic symptoms included two cases with pulsatile tinnitus and six progressive lesions despite adequate medical management.One patient was treated prior to major cardiac surgery with expected prolonged hypotension.High-grade luminal narrowing with insufficient collaterals was the reason for treatment in 24 patients and in six the intention was to improve collateral flow to the territory of an occluded cerebral vessel.A loading dose of 600 mg clopidogrel and 500 mg acetylsalicylic acid (asa) was given 24 hours prior to treatment.In clopidogrel low -responders, prasugrel or ticagrelor was used as a substitute.The duration of dual antiplatelet treatment was extended to 12 months.After 1 year, asa was continued for life.Patients requiring anticoagulation were kept on two antiplatelets and one anticoagulant for 1 year (triple therapy) followed by one anticoagulant and asa.During the procedure, (b)(4) units of heparin and 500 mg asa were administered intravenously after groin puncture and 500¿1,000 mg thiopental immediately before deployment of the stent.A femoral or brachial approach was used in all cases except one due to vessel tortuosity, and direct carotid puncturewas performed.For all approaches non-medtronic (mdt) guide catheters was used.The lesions were passed under roadmap conditions with a non-mdt micro guidewire, either directly or supported by a non-mdt microcatheter.Direct stenting was preferred, and pre-dilatation was reserved for tight lesions.The stent diameter was chosen slightly undersized compared to the vessel diameter proximal and distal to the lesion, and the device length as short as possible to just cover the plaque.Stent deployment was controlled under fluoroscopy and balloon inflation was stopped after full expansion not exceeding the nominal pressure.Regular control angiography was performed after 6 and 12 weeks, 6 and 12 months, and yearly thereafter.Treatment was successful in 100 lesions.In 13 lesions it was impossible to place the des (no=7 non-mdt, no=3 resolute integrity, no=3 both des attempted).On one occasion, treatment with resolute integrity was successful after failure of the non-mdt des.In four lesions a residual stenosis >50 % remained.Intra-procedural one guidewire perforation of a distal middle cerebral artery branch was sealed with coils and glue.This patient experienced a hemorrhagic stroke.Two carotid cavernous fistulae were successfully treated, endovascularly, without clinical symptoms.Five patients had intracranial dissections without extravasation.Three were treated by implantation of a stent or flow diverter.One posterior inferior cerebellar artery (pica) infarct was related to a v4 dissection and was clinically evident with dizziness.Dissections of the cervical access vessel occurred in two patients.In the first patient, the internal carotid artery was reconstructed by stent angioplasty.No new neurologic deficit was observed.In the second patient, the dissection was caused by direct carotid puncture and was surgically repaired.In the same patient, the non-mdt des detached pre maturely and was fixed by percutaneous transluminal angioplasty (pta).This patient developed dysphagia and dysarthria.Eight ischemic and two hemorrhagic procedure-related strokes occurred.Four ischemic strokes were caused by perforator occlusion after treatment of verte brobasilar stenoses.Three strokes were embolic and in one case the etiology could not be determined.One hemorrhagic stroke was attributable to guidewire perforation and the second was a hemorrhage into a pre-existent infarct in a different vessel territory.Deterioration of the modified rankin score (mrs) at discharge was seen in 7 patients with a permanent deficit in 3.Angiographic follow-up was available for 83 of 100 successfully treated lesions with an average of 355 days.Sixty-three patients completed 6 month and 45 patients >1 year follow-up.Asymptomatic in stent restenosis (isr) occurred in three patients after treatment with the resolute integrity des.Two patients died during follow-up due to concomitant cardiac disease and one due to a stroke in a different vessel territory.Three patients experienced a stroke beyond 30 days.Two were ipsilateral strokes in the territory of the treated artery.None of the ipsilateral strokes was associated with a restenosis.The first patient had a proven thrombus within the stent despite adequate platelet inhibition.Since the same patient died from an embolic stroke in another territory more than 1 year after treatment, etiology was considered an embolism of unknown source or coagulopathy.The second patient had a punctate thalamic infarct just beyond 30 days after treatment of a basilar artery stenosis.This infarct was considered to be due to small vessel disease by the treating neurologist.
|
| |
|
Manufacturer Narrative
|
|
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.
|
| |
|
Search Alerts/Recalls
|
|
