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

Model Number	FC-4-8-3D
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	03/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that an axium framing coil prematurely detached inside a microcatheter.The patient was being treated for an unruptured, saccular aneurysm in the right 6x6 supraclinoid.The max diameter was 6.1mm and the neck diameter was 3.75mm.The patient's blood flow was normal and vessel tortuosity was moderate.The devices were prepared according to the instructions for use (ifu).  while advancing, a fc-4-8-3d coil detached prematurely inside the sl10 micro catheter.The coil was deployed halfway into the aneurysm and half was still inside the sl10 micro catheter.Multiple attempts at retrieving the malfunctioned coil was performed until successful retrieval was achieved with medtronic 6x40 solitaire device.Surgical intervention was not required.The pushwire was not bent or broken.There was no friction or difficulty during delivery.The physician did not reposition or attempt to detach the coil.The physician did not rotate the delivery pusher during procedure.Continuous flush was administered during the procedure. no symptoms were reported.Ancillary devices: 8fr terump sheath, penumbra neuron max.088 guidecatheter, stryker sl10 micorcatheter, medtronic marksman microca theter, stryker synchro 14 soft and scientia vascular aristotle 24 guidewire, ev3 7mm snare, medtronic 3x20 solitaire and medtronic 6x40 solitaire.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: AXIUM FRAMING COIL
• 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: 14017966
• Report Number: 2029214-2022-00583
• Device Sequence Number: 6298011
• Product Code: KRD
• UDI-Device Identifier: 00847536034129
• UDI-Public: 00847536034129
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162704
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2022

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: 08/12/2023
• Device Model Number: FC-4-8-3D
• Device Catalogue Number: FC-4-8-3D
• Device Lot Number: B068930
• 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: 03/23/2022
• Initial Report FDA Received Date: 04/05/2022
• Date Device Manufactured: 08/12/2020
• 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 Age: 79 YR
• Patient Sex: Female
• Patient Weight: 77 KG