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

Model Number 105-5078-153

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

Patient Problems Intracranial Hemorrhage (1891); Ischemia (1942); Paresis (1998); Perforation (2001); Dysphasia (2195); Unspecified Nervous System Problem (4426)

Event Date 08/27/2007

Event Type  Injury  

Event Description

Nguyen, t.N., roy, d., guilbert, f., raymond, j., <(>&<)> weill, a.(2008).Endovascular trapping of a vertebral artery segment to control pica origin tearing.Journal of neuroimaging, 18(4), 418¿421.Doi: 10.1111/j.1552-6569.2007.00195.X medtronic literature review found a report of patient complications in association with hyperglide balloon and rebar microcatheter.The purpose of this article was to describe a technique of isolating the subarachnoid segment of the vertebral artery using two balloons to trap flow to a ruptured posterior inferior cerebellar artery (pica) aneurysm allowing time to coil the parent artery with the aneurysm.The article does not state any technical issues during use of the hyperglide or rebar.The following intra- or post-procedural outcomes were noted: during placement of the first coil, aneurysm perforation was noted.Despite conventional measures to manage the perforation (anticoagulation reversal, balloon inflation, placement of a second coil, and ventricular drain), contrast extravasation persisted after 45 minutes.A second balloon was positioned via the right vertebral artery at the right vertebrobasilar junction and inflated.The first balloon was pulled back, inflated, allowing trapping of the ruptured site.The aneurysm and adjacent vertebral segment were rapidly coiled to occlude the ruptured site under local flow arrest.The patient awoke with dysarthria, persistent 4/5 left hemiparesis, left hypoesthesia, and dysphagia.A head ct revealed higher density of subarachnoid hemorrhage in the basal cisterns diffusely, and no increase in ventricular size.The patient was discharged to rehabilitation 2 weeks after hospitalization, with improvement of her neurological status.At follow-up, mri obtained 2 months later revealed punctate ischemia in the left cerebellum and left medulla.At 6-month clinical follow-up, the patient had good recovery of the left hemiparesis, with a modified rankin scale of 1.They continued with left sided hemisensory loss and mild gait ataxia.

Manufacturer Narrative

Nguyen, t.N., roy, d., guilbert, f., raymond, j., <(>&<)> weill, a.(2008).Endovascular trapping of a vertebral artery segment to control pica origin tearing.Journal of neuroimaging, 18(4), 418¿421.Doi: 10.1111/j.1552-6569.2007.00195.X see manufacturer report # 2029214-2022-01372 for another report from this article.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: 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: 15230145
• MDR Text Key: 297949249
• Report Number: 2029214-2022-01373
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 105-5078-153
• Device Catalogue Number: 105-5078-153
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2022
• Initial Date FDA Received: 08/15/2022
• 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): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female