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

Model Number UNK-NV-REBAR

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

Patient Problems Abscess (1690); Hemorrhage/Bleeding (1888); Pain (1994); Skin Discoloration (2074); Burning Sensation (2146); Swelling/ Edema (4577)

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

Lilje d, wiesmann m, hasan d, ridwan h, holzle f, nikoubashman o.Interventional embolization combined with surgical resection for treatment of extracranial avm of the head and neck: a monocentric retrospective analysis.Plos one (2022).17(9): e0273018.Doi: 10.1371/journal.Pone.0273018.A2 34 years is the average age of the patients who participated in the study.A3 female 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

The purpose of the article was to demonstrate the efficacy and feasibility of treating patients with extracranial arteriovenous malformations (avm) of the head and neck with interventional embolization followed by surgical resection.10 patients (8 female, 2 male) were included, with a mean age of 33.5 (11¿61) years who were scheduled for treatment of the avm with interventional embolization followed by surgical resection.In 6 of the 10 patients (60%) the lesion was located in extracranial soft tissue only.In one patient (10%), the lesion was located in bone tissue only.A combined intraosseous and oral soft tissue lesion was seen in the remaining 3 patients (30%).Radiographic resolution was achieved in 62.5% of cases and a significant decrease of symptoms was identified (p = 0.002).None of the patients reported dissatisfaction and no major complications occurred.Patients who had finished treatment were hospitalized for a median of 12 (interquartile range 7¿47) days.All but two patients experienced minor adverse effects, limited to the region of former lesion.Minor side effects included paresthesia, bleeding, discoloration, abscess, swelling and pain.In all cases, side effects were managed conservatively.None of the patients experienced major complications.  an interdisciplinary treatment approach combining neuroradiological interventions with surgical resection appears to be an effective treatment with an acceptable complication rate.Patients treated according to protocol showed a high satisfaction rate, regardless of the radiographic outcome.Standardized follow-up allows for early detection of recurrences and helps with subjective patient satisfaction.There were no device issues reported relating to the use of the rebar, marathon, or onyx.Adverse events included: 1.Paresthesia 2.Bleeding 3.Discoloration 4.Abscess 5.Swelling 6.Pain.

• 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: 17032385
• MDR Text Key: 316298562
• Report Number: 2029214-2023-00870
• 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: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-REBAR
• Device Catalogue Number: UNK-NV-REBAR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2023
• 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): Other
• Patient Age: 34 YR
• Patient Sex: Female