MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SUPPORT GUIDECATHETER; CATHETER, PERCUTANEOUS

Model Number RFXA072-115-08MP

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

Patient Problems Intracranial Hemorrhage (1891); Rupture (2208)

Event Date 07/18/2022

Event Type  Injury  

Manufacturer Narrative

Related to reg report #: 2029214-2022-01230.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

Medtronic received information that a patient treated with multiple devices during a flow diversion (fd) procedure had a rupture of the internal carotid artery.Performed an embolization of an left internal carotid aneurysm (ophthalmic segment) treated with a fd jailing technique (vantage 4.5*20mm flow diverter with phenom 27 microcatheter and a 2x target 11*30 coils with echelon 10 45° microcatheter and navien 6f distal access catheter).After flow diverter deployment, the physician decided to use a hyperglide 5*20mm balloon to perform a tpa, first proximally and then distally.The angiographic check after the tpa showed a distal bleeding caused by the rupture of the left internal carotid.A vessel takedown with coils was performed to arrest the bleeding.The devices were prepared according to the instructions for use (ifu).The catheters were flushed as per ifu.The patient was undergoing treatment for an unruptured, saccular aneurism in the left internal carotid- ophthalmic segment c6.The max diameter was 12.84mm and the neck diameter was 9mm.Vessel tortuosity was moderate.Dual antiplatelet treatment was administered.

• Brand Name: SUPPORT GUIDECATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 15100387
• MDR Text Key: 296561314
• Report Number: 2029214-2022-01231
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2023
• Device Model Number: RFXA072-115-08MP
• Device Catalogue Number: RFXA072-115-08MP
• Device Lot Number: B260113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2022
• Date Device Manufactured: 09/02/2021
• 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
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 70 KG