MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR REBAR; CATHETER, CONTINUOUS FLUSH

Model Number 105-5081-153

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

Patient Problems Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891); Hemorrhagic Stroke (4417); Heart Failure/Congestive Heart Failure (4446)

Event Date 08/01/2010

Event Type  Injury  

Manufacturer Narrative

Refer to regulatory rep #: 2029214-2022-01504 for related event information.Musahl c, henkes h, vakda z, coburge j, hopf n.Prognostic factors for outcomes after mechanical thrombectomy with solitaire stent.Journal of neuroradiology.(2013) 40, 252-259.Doi: http://dx.Doi.Org/10.1016/j.Neurad.2013.04.001.Age: 58 years is the average age of the patients who participated in the study.Gender: male is the majority of the participants.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

Musahl c, henkes h, vakda z, coburge j, hopf n.Prognostic factors for outcomes after mechanical thrombectomy with solitaire stent.Journal of neuroradiology.  (2013) 40, 252-259.Doi: http://dx.Doi.Org/10.1016/j.Neurad.2013.04.001.Medtronic literature review found reported of patient complications in association with solitaire fr and rebar18 catheter.  the purpose of this article was to identify factors influencing outcomes after thrombectomy with a solitaire stent device.  this study was aimed at identifying prognostic factors influencing angiographic and clinical outcomes, at discharge and at 3 months, after thrombectomy with solitaire.Focused clinical, imaging and logistic variables were evaluated from a single center cohort of 45 consecutive patients.Of the 45 patients, 30 were men and 15 were women, the average age was 58 years.Clinical efficacy at discharge and at 3 months was achieved for 49% and 58% of patients, respectively.Three symptomatic hemorrhages occurred (7%).These involved a 45-year-old patient with terminal internal carotid artery occlusion and severe dwi lesion without flair hyperintensity, treated with iv fibrinolysis and thrombectomy at 372 min, a 37-year-old patient with basilar artery occlusion and non-severe dwi lesion but with flair hyperintensity, treated with thrombectomy alone at 777 min, and a 73-year-old patient with m1 occlusion, non-severe dwi lesion and no flair hyperintensity, treated with iv fibrinolysis and thrombectomy at 360 min.Death rate was 18% due to stroke worsening (six patients, three of whom with symptomatic hemorrhage) or cardiac failure (two patients, post-infectious), and corresponded with three basilar occlusions, two carotid terminal occlusions and three m1 occlusions.No symptomatic hemorrhage nor death was directly related to the thrombectomy procedure itself.The following intra- or post-procedural outcomes were noted: 1.Symptomatic hemorrhages 2.Death rate was 18% 3.Stroke worsening 4.Cardiac failure.

• Brand Name: REBAR
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 15367032
• MDR Text Key: 299357099
• Report Number: 2029214-2022-01507
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 105-5081-153
• Device Catalogue Number: 105-5081-153
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2022
• 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): Other
• Patient Age: 58 YR
• Patient Sex: Male