MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 MARATHON; CATHETER, CONTINUOUS FLUSH

Model Number UNK-NV-MARATHON

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891); Paralysis (1997); Paresis (1998); Visual Disturbances (2140); Dysphasia (2195); Confusion/ Disorientation (2553); Unspecified Nervous System Problem (4426)

Event Date 04/15/2008

Event Type  Injury  

Event Description

V.Panagiotopoulos, e.Gizewski, s.Asgari, j.Regel, m.Forsting and i.Wanke; journal of neuroradiology; 2009; 30 (1) 99-106; embolization of intracranial arteriovenous malformations with ethylene-vinyl alcohol copolymer (onyx); doi.Org/10.3174/ajnr.A1314 medtronic received information in a literature article of patients treated with onyx embolization, marathon cathters, and mirage guidewires having complications.Thepurpose of the article was to report the experience in the treatment of arteriovenous malformations (avms) with ethylene-vinyl alcohol copolymer (onyx).Between july 2002 and january 2008, brain avms were embolized with onyx in 82 consecutive patients in our department.There were 41 females and 41 males with a mean age of 44.2 years (range, 15¿ 85 years).Clinical presentation included symptoms due to intracerebral hemorrhage (n =37), seizures (n =18), nonhemorrhagic neurologic deficits (n =8), headaches (n =9), or incidental symptoms (n =10).  procedure: all procedures were performed with the patients under general anesthesia.  a 6f sheath was placed in the femoral artery, and a 6f gu iding catheter was then inserted in 1 of the main brain feeding arteries (internal carotid or dominant vertebral artery) that supplied the avm.Continuous flushing of the sheath and the guiding catheter was performed with slightly heparinized saline (1000 iu of he parin per liter).Systemic heparin was not administered additionally because it is not routine in our department.A superselective catheterization with flow-directed microcatheters (marathon or ultraflow) and microguidewires (mirage or silverspeed) was performed w ith the tip of microcatheter placed as close as possible to the avm nidus.Angiographic series through the microcatheter with a 3-ml syringe proved to be especially useful for assessing the avm architecture and adjusting the microcatheter tip in a safe and optimal position.Preinterventional identification of normal parenchymal branches arising from the pedicle distally or eloquent branches or iginating proximal to the microcatheter tip that could potentially be occluded due to reflux was of utmost importance.Microangiography was also useful in evaluating the local avm flow and illustrating the anatomy of the draining vein.The concentration of onyx was selected according to the size of the feeding vessel.If a small feeding vessel (only slightly above normal vessel diameter) was present, onyx 18 was used; if a large feeding vessel (at least 3 times the normal diameter) was present, onyx 20 was used.Because there is very little difference between these 2 viscosities, we believe that using one or the other viscosity would not make much difference, with the exception of onyx 34, which was selected for occlusion of a very high-flow fistulous nidus, partly because the risk of extended venous migration of the liquid embolic agent was estimated to be high.In case of very large fistulous vessels, a microballoon was used to block the flow proximally.The microcatheter was flushed with normal saline and filled with dimethylsulfoxide (dmso).Afterward, 0.25-ml onyx was injected slowly ( <(><<)>0.1 ml/ min) into the microcatheter.Injection beyond the catheter tip into the avm was monitored fluoroscopically by roa d-mapping.In case of reflux around the catheter tip of >1 cm, we temporarily discontinued the injection of onyx for 1¿2 minutes to form a cast around the tip of the microcatheter and, thereafter, performed a second penetration of the nidus (plug and waiting tech nique).Every effort was made to occlude the arterial compartment of the avm first to avoid bleeding complications associated with early occlusion of venous drainage.This was accomplished by redirection of onyx through short breaks of onyx application, lasting between 30 seconds and 1 minute, and, thereafter, performing a further injection.Injection of the onyx into the draining veins was allowed only in their origin and only after occlusion of the arterial nidus compartment.Angiographic control was performed through the guiding catheter during the injection intervals to evaluate the residual flow to the avm or nontarget embolization.In case of increased resistance of the injection, further application of onyx was discontinued, to avoid rupture of the microcatheter or vessels.The microcatheter was removed by slowly increasing traction.In case of incomplete occlusion of the avm and residual flow, another feeding pedicle was catheterized with a new microcatheter system and further onyx application was attempted.Postembolization the patient was transferred to the intensive care unit for 48-hour monitoring of vital functions.The systolic blood pressure should be kept within normal limits with a maximum of 150 mm hg to avoid additional hemodynamic changes of the brain circulation and especially within the nonembolized part of the avm.Steroids were given orally (4 mg x 4/day dexamethasone) for 4 days after the intervention to prevent or reduce perinidus edema.Results:  initial complete obliteration at the end of all embolization procedures was achieved in 20/82 patients (24.4%).An average of 75% (range, 30%¿100%) volume reduction was achieved at the end of the endovascular procedures.After a mean follow-up of 8.8 months (range, 0 ¿57 months) of the 20 initially completely embolized avms, 4 angiographic recurrences were evident between 2.5 and 4 months; 2 of them were minimal.Three of them underwent surgical excision, whereas 1 patient is scheduled for a further embolization treatment.The rate of complete embolization at follow-up was 19.5% (16/82 patients).Neurosurgical removal of avms was performed in 49/82 patients after embolization.Postembolization radiosurgery was performed in 3 partially occluded avms.The rest of the patients are scheduled for angiographic control and evaluation of further treatment.Complete embolization was achieved through a single pedicle in 6 avms, through 2 pedicles in 8 avms, and through >3 pedicles in 3 avms.According to the mrs, 10 patients (10/82) experienced nondisabling (mrs, 1¿2) neurologic deficits (12.2%), whereas 6 patients (6/82) experienced disabling (mrs >3) neurologic deficits (7.3%) immediately after the embolization procedure.The overall periprocedural new clinical morbidity related to embolization was 19.5% (16/82 patients).Nondisabling neurologic deficits included 1 case of a slight arm paresis, 1 apraxia of the upper limb, 1 case of discrete ataxia, 1 case of third nerve palsy, and 6 visual field deficits, whereas disabling neurologic deficits included 5 cases of postinterventional hemiparesis and 1 case of lower limb paresis.Among the patients with deficits, 6 intracerebral hemorrhages, 1 intraventricular hemorrhage, 3 subarachnoid hemorrhages, and 3 infarcts/perfusion deficits were responsible for the neurologic changes, whereas in 3 cases, a clear cause was not identified.A microballoon that had been used for preventing coil migration into the venous side of a fistulous part of an avm was stuck and could not be removed.This was the cause of 1 of the previously mentioned infarcts resulting in slight transient hemiparesis.One trapped microcatheter in the posterior circulation did not add clinical morbidity to our cohort.The periprocedural mortality rate related to embolization was 2.4% (2/82 patients) due to postinterventional intracerebral bleeding.One of these patients experienced a large intracerebral hemorrhage 58 hours after the second session of a staged embolization for a grade ii precentral avm.We noted limited migration of onyx into the venous side without obstruction of the superficial venous drainage.The second patient bled significantly immediately after the end of the second session of a staged embolization for a grade v cerebellar avm.The patient immediately underwent surgery with evacuation of the hematoma and removal of the residual avm.The patient bled again 8 hours after surgery and died.Blood pressure ranged within normal limits intra- and postinterventionally in both cases.Hemorrhagic clinical presentation before embolization was present in both patients.A clear reason for these bleedings was not identified.Possibly hemodynamic changes in the normal parenchyma led to a perfusion breakthrough hemorrhage.The surgeons did not reveal venous blockage with onyx, but it is sometimes not obvious to them.Long-term follow-up (mean, 14 months; range, 3¿49 months) is available for the 12 among 16 patients who experienced new clinical morbidity immediately after the embolization.Four patients were not available for long-term follow-up; 1 of them with an initially disabling clinical complication is still in a rehabilitation program.However, concerning 3 patients with a nondisabling deficit, 1 was lost due to relocation, whereas 2 are scheduled for clinical assessment in 5 months.Concerning the clinical course of the initially nondisabling neurologic deficits in 7 patients available for follow-up, 1 case of paresis of the arm, 1 case of upper limb apraxia, and 2 cases of visual field deficits showed complete resolution.The remaining initially nondisabling deficits (n =3) showed partial or no improvement.At follow-up, the permanent nondisabling (mrs, 1¿2) embolization-related clinical morbidity rate was 5.1% (4/78), including 1 patient with an initially disabling hemiparesis immediately after the embolization whose condition improved to a non disabling residual hemiparesis at follow-up.Concerning the initially disabling neurologic deficits in 5 patients available for follow-up, 1 case of hemiparesis showed complete resolution, 1 patient improved to a nondisabling residual hemiparesis, 2 patients improved but remained disabled, and 1 patient did not show any improvement, whereas 1 patient is still in a rehabilitation program and is not available for a follow-up beyond 3 months.At the end of the follow-up, disabling (mrs, >3) embolization-related clinical morbidity was 3.8% (3/78 patients).The overall permanent morbidomortality rate related to the embolization procedure was 11.3%.

Manufacturer Narrative

See attachments for literature article.Event related to regulatory reports: 2029214-2023-01178 and 2029214-2023-01179 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.

• Brand Name: MARATHON
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 17396733
• MDR Text Key: 319779950
• Report Number: 2029214-2023-01180
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-MARATHON
• Device Catalogue Number: UNK-NV-MARATHON
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR