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

Model Number UNK-NV-MICROCATH

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

Patient Problems Stroke/CVA (1770); Intracranial Hemorrhage (1891); Paresis (1998)

Event Date 05/04/2013

Event Type  Injury  

Event Description

Grandhi, r., zwagerman, n.T., linares, g., monaco, e.A., jovin, t., horowitz, m., & jankowitz, b.T.(2014).Onyx embolization of infectious intracranial aneurysms.Journal of neurointerventional surgery, 6(5), 353¿356.Https://doi.Org/10.1136/neurintsurg-2013-010755.Medtronic review of the literature article found a retrospective review of patients with infection intracranial aneurysms (iias) treated via onyx embolization at a single facility between 2010 and 2012.8 patients with 16 iias were treated.Onyx was delivered via either an echelon or marathon microcatheter.There was no reported device malfunction.One patient experienced a symptomatic intraparenchymal hemorrhage (iph) which required emergency craniotomy for clot evacuation 4 days after initial iia treatment.A subsequent angiogram revealed four new iias which were then embolized.Less than a week after this second embolization another new iia was found and treated on follow-up.Though other events were reported in the article, they were associated with/caused by the index patient conditions and not related to the onyx or the embolization procedure.

Manufacturer Narrative

Associated with mdr #: 2029214-2023-01407.D1, d4: the catheter used in the index procedure was possibly either an echelon microcatheter or marathon catheter, however the catheter model and lot number for the device used in the procedure was not specified in the 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: NV MICROCATHETER
• 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: 17557646
• MDR Text Key: 321260881
• Report Number: 2029214-2023-01408
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-MICROCATH
• Device Catalogue Number: UNK-NV-MICROCATH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• 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): Required Intervention
• Patient Age: 28 YR