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

Model Number 105-5082-130

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

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Vasoconstriction (2126); Rupture (2208); Stenosis (2263); Obstruction/Occlusion (2422); Thromboembolism (2654); Unspecified Nervous System Problem (4426)

Event Date 06/16/2021

Event Type  Injury  

Manufacturer Narrative

G2: citation: authors: gündogmus, c.A., sabet, s., baltacioglu, n.A., türeli, d., bayri, y., <(>&<)> baltacioglu, f.Long-term results and comparison of flow re-direction endoluminal device and pipeline embolization device in endovascular treatment of intracranial carotid aneurysms.Interventional neuroradiology: journal of peritherapeutic n 28(3):302-310 2022.Doi:10.1177/15910199211030780 a.2.This value is the average age of the patients reported in the article as specific patients could not be identified.A.3.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Earliest date of publication used for date of event no unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.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

Gündogmus ca, sabet s, baltacioglu na, türeli d, bayri y, baltacioglu f.Long-term results and comparison of flow re-direction endoluminal device and pipeline embolization device in endovascular treatment of intracranial carotid aneurysms.Interventional neuroradiology: journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences.2022;28(3):302-310.Doi:10.1177/15910199211030780 medtronic literature review found a report of patient complications in association with the pipeline device, navien catheter, and rebar 27 and marksmen microcatheters.The purpose of this article was to compare the efficacy, safety, and long-term outcomes of two flow diverters, i.E., pipeline embolization device and flow re-direction endoluminal device, in the treatment of distal carotid aneurysms.A total of 138 patients with 175 aneurysms were included from february 2012 to september 2019.Ninety-nine aneurysms were treated with flow re-direction endoluminal device and 76 with pipeline embolization device.Eight males and 47 females were included with an average age of 50 years.A total of 155 devices were used for the treatment of 175 aneurysms.Eighty-four fred and 71 ped were deployed to treat 99 (57%) and 76 (43%) aneurysms, respectively.All procedures were performed under general anesthesia and by a single operator.A standard triaxial approach was used with a transfemoral 6f long introducer sheath and a 6f distal access catheter, either navien (covidien vascular) or sofia (microvention), placed in the distal petrous segment of ica.Parent artery measurements were made using two and three-dimensional images.A 0.027 inch microcatheter was used in combination with a 0.014/0.016 inch microguidewire to by-pass aneurysms neck: rebar 27 (covidien vascular), marksman (covidien vascular), or headway 27 (microvention) microcatheters were used for ped deployments; and headway 27 microcatheter for fred deployments.Additional coiling was performed to aneurysms >10 mm through a jailed microcatheter.The microcatheter was positioned inside the aneurysm sac before flow diverter deployment, and coiling was commenced after the device was deployed.The following technical issues were noted: -out of 155 devices deployed, five had to be removed during the same session due to deployment failure.Device deployment failure was observed with five flow re-direction endoluminal devices and two pipeline embolization devices.Two cases were complicated by iatrogenic total ica occlusion due to deployment failure, namely because of proximal ends of one fred and one ped not expanding.Adequate ipsilateral flow from contralateral ica and posterior circulation proved critical in both patients recovering from anesthesia without any neurologic sequela.In addition, it was observed that the aneurysms were also occluded along with the parent artery.-another patient presented with subarachnoid hemorrhage due to rupture of index aneurysm on the 10th -day after flow diversion with ped.Dsa revealed the distal end of the stent migrated proximally and re-diverted flow into the aneurysm sac and led to bleeding.However, this also remodeled the aneurysm neck, allowing the coiling of the aneurysm while maintaining ica patency.The patient was discharged without sequelae.-rupture of a marksman microcatheter was observed in one patient during the passage of a first-generation ped through an acute cervical loop.The device and microcatheter were taken out, and another ped was delivered uneventfully via a headway 27 microcatheter.The following intra- or post-procedural outcomes were noted: -all the mortality and morbidity were related to hemorrhagic complications.The overall mortality rate is 3.6% (5 of 138); four pati ents treated with fred and one patient treated with ped died.One patient who was initially treated with ped required two additional peds to be deployed telescopically due to early spontaneous rupture of the treated aneurysm, but died 30 days later.-one patient treated with flow diversion only, with ped, was readmitted with spontaneous rupture on the 16th day post-procedure.Emergent angiography showed no active filling of the aneurysmal sac.Nevertheless, two additional peds were deployed into the lumen of the current device in a telescopic fashion.Re-bleeding did not occur.However, severe cerebral vasospasm leading to brain stem infarction resulted in severe disability (mrs=5).-two severe in-stent stenoses occurred with each device.One patient treated with bilateral ped developed severe stenosis at the middle part of the right device and the distal end of the left device lumens.The patient was asymptomatic and remained so.The degree of stenoses did not show any interval change.  -a total of six devices, four fred and two ped, had moderate in-stent stenosis.  all were asymptomatic and thus did not require further intervention.-two patients treated with fred and one patient treated with ped were found to have occluded ophthalmic arteries, and none had visual deficits.A1 segments of all patients with jailed aca were either occluded or had decreased calibration at controls.Occlusion or diminished caliber was observed in 43.9%, and 75% of jailed pcomas, respectively, with fred or ped with no statistical significance.None of the patients with jailed arteries had any relevant clinical events during postprocedure and follow-up -there were six cases, five treated with fred and one with ped, complicated with early thromboembolism.The thromboembolic event occ urred in the patient treated with ped while doing diagnostic angiography to the contralateral left ica.The patient was discharged with no deficits.-only one case was complicated with a systemic hemorrhage during follow-up; one ped patient, receiving prasugrel, had gastrointestinal bleeding on the 50th day post-treatment, which prompted cessation of antiaggregant temporarily.The patient did not have ischemic events afterward.-occlusion rates at the 6th and 12th months and during the last follow-up were similar for flow re-direction endoluminal device (81%, 84%, and 90%) and pipeline embolization device (82%, 85%, and 93%).Additional coiling was used in the treatment of 54 aneurysms (37 treated with fred and 17 with ped).Occlusion rates were also similar after stand-alone use without coiling.

• Brand Name: REBAR
• 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: 17695175
• MDR Text Key: 322808926
• Report Number: 2029214-2023-01598
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K093750
• 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: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 105-5082-130
• Device Catalogue Number: 105-5082-130
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2023
• 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): Disability; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female