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

Model Number	QC-4-12-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding an axium coil that failed to detach.That patient was undergoing a coil embolization procedure to treat a ruptured saccular right posterior communicating aneurysm.The aneurysm max diameter was 5.24mm and the neck diameter was 2.1mm.Blood flow was normal.Vessel tortuosity was moderate.It was reported that the axium coil and all accessory devices were prepared according to the instructions for use (ifu).The coil was deployed but could not be detached with the instant detacher (id).3 attempts were made to detach the coil with the id without success.2 attempts were then made at manual detachment with the hypotube but this was also unsuccessful.The coil was removed and replaced with an axium 4x10 coil that was delivered and detached with the same id without issue.It was noted there was no problem with the id.There was no harm or injury to the patient.Ancillary devices: cordis 6f sheath, chaperon 6f guide catheter, excelsior sl-10 microcatheter, synchro 14 guidewire.
Additional Manufacturer Narrative
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: 12805120
• Report Number: 2029214-2021-01452
• Device Sequence Number: 17514191
• Product Code: KRD
• UDI-Device Identifier: 00847536029590
• UDI-Public: 00847536029590
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/19/2023
• Device Model Number: QC-4-12-HELIX
• Device Catalogue Number: QC-4-12-HELIX
• Device Lot Number: A995941
• 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: 11/05/2021
• Initial Report FDA Received Date: 11/12/2021
• Date Device Manufactured: 03/19/2020
• 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
• Patient Sex: Female