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

Model Number	QC-7-30-HELIX
Medical Device Problem Codes	Stretched (1601); Unintended Movement (3026); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Stenosis (2263); Numbness (2415)
Date of Event	06/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received a report that on (b)(6) 2024, more than one month after the patient was found to have a right vertebral artery dissecting aneurysm in an external hospital, the patient was admitted to the hospital for vertebral artery aneurysm with dissection in the outpatient department.The patient underwent intracranial stent-assisted intracranial artery embolization under general anesthesia.After confirming the position by angiography, used the prowler plus microcatheter carrying the synchro-2 micro-guidewire through the middle catheter to enter the distal end of the loaded tumor segment.Then the headway-17 microcatheter carrying the synchro-2 micro-guidewire through the middle catheter to enter the aneurysm cavity.After the angiography confirmed that the microcatheter position was satisfactory, an enterprise 4.5mm*22mm stent was first implanted from the prowlerplus microcatheter to cover the aneurysm neck.Then three coils were filled from the headway-17 microcatheter.When the last coil was filled, a long section of the coil was stretched, which made it impossible to continue implanting the coil, also could not retrieve and remove it.Then, an enterprise 4.5mm*37mm stent was implanted through the prowlerplus microcatheter to cover the neck of the aneurysm and the coming out coil.The final angiography showed dense embolism near the aneurysm and good coverage of the stent position.The right vertebral artery was well visualized.The coil stretched segment extended down from the right vertebral artery stent to the right femoral artery groin.The patient was hospitalized for observation until 6.30.On june 26, the patient reported numbness in the left face and limbs, which was considered to be caused by severe stenosis of the right middle cerebral artery.No obvious falling off problem was found during the observation period, but there was a certain risk of embolism in the future.The consultation believed that the risk of secondary surgery was high, and the patient was discharged after consultation with the patient.No obvious problems were found in the patient's re-examination on 7/12.
Additional Manufacturer Narrative
Additional information received reported the event was already reported in regulatory report: 9612164-2024-02965.Any additional information will be included in that report.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
The event is no longer a reportable event.Mdr decision corrected too not reportable.No additional supplemntal mdrs are required unless additional information received makes the event reportable.Due to gch functionality, the complaint flag cannot be flipped to 'no' as a regulatory report exists in this pe.
Event or Problem Description
Additional information received reported most of the coil remains in patient.The cause of the stretch was not determined.There were no issues that resulted in the coil stretch.The coil was implated in the correct location.The coil loop was in the parent vessel.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 20350851
• Report Number: 2029214-2024-01743
• Device Sequence Number: 7931520
• Product Code: KRD
• UDI-Device Identifier: 00847536037458
• UDI-Public: 00847536037458
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/03/2024

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: 07/01/2026
• Device Model Number: QC-7-30-HELIX
• Device Catalogue Number: QC-7-30-HELIX
• Device Lot Number: 226870749
• 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: 09/30/2024
• Supplement Date Received by Manufacturer: 10/12/2024; 11/07/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 11/06/2024; 12/03/2024
• Date Device Manufactured: 07/01/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female