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

Model Number	QC-10-30-HELIX
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Thrombosis/Thrombus (4440)
Date of Event	04/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that an axium coil detached prematurely after non-detachment and required medical intervention to remove.The patient was being treated for an unruptured, saccular aneurysm in the right internal carotid artery (ica).The max diameter was 16mm and the neck diameter was 10mm.Patient blood flow was normal and vessel tortuosity was moderate.The devices were prepared according to the instructions for use (ifu).  the doctor found an echelon microcatheter inside the aneurysm, a bypass flow diverter had already been placed in the artery because the neck of the aneurysm was very large, when he was placing the last medtronic coil he did not release despite using the releaser coil, when retracting the pusher of the coil, the entire coil comes into the patient's artery and is released spontaneously in the artery, remaining floating in the artery, while coil recovery maneuvers were performed, a thrombus appeared in the artery and in the diverter occluding the entire middle brain and the anterior brain, they placed bolus tirofiban and in continuous infusion, it was possible to remove the fragmented and entangled coil in the recovery loop without complications and the patient recovered cerebral blood flow.No complications.What was recovered from the coil came out frayed and entangled in the retrieval handle, another part of the coil remained inside the patient, trapped in the flow diverter that had been placed on the patient.A retriever handle was used to remove the coil.The pushwire was not bent or broken.There was no friction or difficulty during delivery.The physician did not reposition the coil.He did attempt to detached the coil.Two attempts were made with the instant detacher.One instant detacher was used.No manual attempts were made.Continuous flush was administered during the procedure.Did not release the coil with the releaser, after using it twice and when removing the coil a little, it released spontaneously in the artery, leaving the coil floating.The coil released in the artery caused a thrombus to appear and it was time to place a bolus and infusion of tirofiban. it was necessary to use a coil recovery loop to remove the coil from the artery, it was done without complications.The event lead to or extended patient hospitalization.  ancillary devices: echelon 145-5091-190, lot: b311166 microcatheter.
Additional 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 or Problem Description
Additional information received reported that a coil was used before the incident, without any complications.
Event or Problem Description
Additional information received reported that one coil had been implanted before and after the coil malfunctioned.
Additional 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 HELIX
• Common Device Name: 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: 14139260
• Report Number: 2029214-2022-00653
• Device Sequence Number: 12335202
• Product Code: KRD
• UDI-Device Identifier: 00847536037519
• UDI-Public: 00847536037519
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/09/2024
• Device Model Number: QC-10-30-HELIX
• Device Catalogue Number: QC-10-30-HELIX
• Device Lot Number: 222561077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2022
• Supplement Date Received by Manufacturer: 04/28/2022; 06/24/2022
• Initial Report FDA Received Date: 04/18/2022
• Supplement Report FDA Received Date: 05/26/2022; 07/19/2022
• Date Device Manufactured: 07/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female