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

Model Number UNK-NV-ECHELON

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

Patient Problems Vasoconstriction (2126); Dysphasia (2195); Hydrocephalus (3272)

Event Date 04/26/2021

Event Type  Injury  

Manufacturer Narrative

Reported patient age ((b)(6) years) indicates the mean age of patients included in the endovascular embolization treatment group reported in the article.Reported patient age (male) indicates the majority of patients included in the endovascular embolization treatment group reported in the article.Related medtronic ancillary device: axium coils - a separate report submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

Kang hu, genping cai, liang fu, lili huang, wei huang, wenhao wang, changchun liu.(2021).Effects of surgical clipping and endovascular embolization on the recovery of oculomotor nerve paralysis caused by posterior communicating artery aneurysm.Neurology asia, 26(3), 471¿478.Https://doi.Org/10.54029/2021vnw.Abstract background and objectives: our study aimed to explore the therapeutic effects of surgical clipping and endovascular embolization on the recovery of oculomotor nerve paralysis (onp) caused by posterior communicating artery aneurysm (pcomaa).Methods: the clinical data of patients with intracranial pcomaa and onp were retrospectively analyzed.All patients were treated with surgical clipping or endovascular embolization, then followed up for no less than 12 months.Logistic regression analysis was performed to analyze the potential risk factors influencing onp recovery.Results: among 128 patients of onp caused by pcomaa, 96 patients were treated with surgical clipping and 32 patients with endovascular embolization, respectively.Time from initial onp onset to complete or partial recovery was 85.3 ± 36.8 days for patients receiving surgical clipping, and 135.7 ± 41.3 days for patients treated with endovascular embolization.The recovery rate was 94 (97.9%) in the surgical clipping group and 22 (68.8%) in the endovascular embolization group, and significant difference was shown between the two groups (p 0.001).Logistic regression analyses demonstrated that the complete or partial recovery of onp in the surgical clipping group was significantly better than that in the endovascular embolization group (or, 5.582; 95%ci,.023-15.405; p 0.001).Moreover, time from initial symptom onset to receiving treatment also affect onp recovery (or, 0.893; 95% ci, 0.820-0.972; p = 0.009).Conclusion: surgical clipping was superior to endovascular embolization in the recovery of onp caused by pcomaa, and patients who received early intervention could result in better onp recovery.Medtronic review of the literature article found that the 32 patients who were treated with endovascular embolization were treated with axium coils delivered through echelon microcatheters.Those with wide neck aneurysms additionally had a solitaire stent placed; however, these cases were not specified in the article.Those treated with surgical clipping were not treated with a medtronic device.All patients treated had pre-existing oculomotor nerve paralysis (onp) caused by posterior communicating artery aneurysm (pcomaa).The average age of the endovascular embolization group was 52 years and the majority of patients (53.1%) were male.The article reviewed patient recovery from pre-existing onp symptoms as well other post-operative adverse events.10 patients did not have resolution of onp symptoms and 12 had only partial recovery.Serious post-operative adverse events described include: 6 patients had post-operative hydrocephalus.For 5 of these patients, no additional treatment was described.However 1 patient required ventriculo-peritoneal shunt placement after multiple lumbar punctures to release the blood cerebrospinal fluid.1 patient who had significant cerebral vasospasm.1 patient had developed aphasia.

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.

Event Description

Additional information received reported that there had never been an adverse event related to medtronic products that affected the success or failure of the operation.Axium coils, echelon microcatheters, and solitaire stents were routinely used for aneurysm interventional surgery in this hospital.

• Brand Name: ECHELON
• 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: 12835995
• MDR Text Key: 286144997
• Report Number: 2029214-2021-01497
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-ECHELON
• Device Catalogue Number: UNK-NV-ECHELON
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2021
• 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; Disability
• Patient Age: 52 YR
• Patient Sex: Male