MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM FRAMING COIL; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number FC-7-30-3D

Device Problems Break (1069); Stretched (1601)

Patient Problems Stroke/CVA (1770); Device Embedded In Tissue or Plaque (3165)

Event Date 06/26/2023

Event Type  malfunction  

Event Description

Medtronic received information that a framing coil stretched and broke.The damaged section was in the pushwire proximal segment.The patient had an associated right side stroke.During the retraction of the 7x30 frame 3d, the coil stretched.Attempted to snare the coil; upon snaring, the coil broke off and remained in the patient.Once imaging was obtained, the internal carotid artery (ica) had clotted off.Attempted to aspirate but was unsuccessful.There was no friction or difficulty during delivery or testing.Continuous flush was administered during the procedure.The physician repositioned the coil during the procedure 3 times.The coil was not implanted at the intended location.Attempted to snare the coil but failed, then the ica clotted off.The pushwire was not bent or broken.The physician did not rotate the delivery pusher during the procedure.Continuous flush was administered during the procedure.The patient was being treated for neurovascualr abnormalities.It was not in the eloquent region.Patient blood flow was low and vessel tortuosity was severe.

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.

• Brand Name: AXIUM FRAMING COIL
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• 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: 17221235
• MDR Text Key: 318091294
• Report Number: 2029214-2023-00991
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536034273
• UDI-Public: 00847536034273
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162704
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FC-7-30-3D
• Device Catalogue Number: FC-7-30-3D
• Device Lot Number: B248729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2023
• Date Device Manufactured: 08/12/2021
• 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 Age: 10 MO
• Patient Sex: Male