MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	QC-7-30-3D
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that an axium coil prematurely detached.The patient was being treated for a neurovascular abnormality.It was no in the eloquent region.Patient blood flow was normal and vessel tortuosity was moderate.The devices were prepared according to the instructions for use (ifu).  while the coil was being deployed on the arteriovenous fistula (avf) lesion, it was detached in advance and pushed into the microcatheter.The coil was implanted at the intended location and remain in the patient.No surgical or medical intervention was required.The pushwire was not bent or broken.There was no friction or difficulty during deployment.The physician did not reposition the coil.They did not attempt to detach the coil.They did not rotate the delivery pusher during the procedure.Continuous flush was administered during the procedure.No symptoms were reported.Ancillary devices: sl10 microcatheter additional information received reported the event involved two different axium coils with the same lot number.
Additional Manufacturer Narrative
Event related to regulatory report: 2029214-2022-00446.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AXIUM 3D
• 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: 14311276
• Report Number: 2029214-2022-00790
• Device Sequence Number: 5313974
• Product Code: KRD
• UDI-Device Identifier: 00847536030060
• UDI-Public: 00847536030060
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/05/2022

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: 07/12/2024
• Device Model Number: QC-7-30-3D
• Device Catalogue Number: QC-7-30-3D
• Device Lot Number: B233302
• 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: 04/12/2022
• Initial Report FDA Received Date: 05/06/2022
• Date Device Manufactured: 07/13/2021
• 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
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 59 KG