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

Model Number	APB-1-2-3D-ES
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2022
Type of Reportable Event	Malfunction
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 prematurely detached.The patient was being treated for a ruptured fusiform aneurysm in the middle carotid artery (mca).The max diameter was 3mm and the neck diameter was 4mm.Patient blood flow was normal and vessel tortuosity was moderate.The devices were prepared according to the instructions for use (ifu).  a coil form another company was deployed.Then a second coil which was from medtronic was prematurely detached.Some coil part came in to the parent artery.Physician then chose to deploy an atlas stent.The coil remains in patient.The coil was implanted at the intended location.No surgical or medical intervention is required.The pushwire was not bent or broken.The physician repositioned the coil 2 times.The physician attempted to detach the coil.They tried 2 times with the instant detacher.They tried 1 time using the manual method.1 instant detacher was used.The physician didn't not rotate the delivery pusher during the procedure.Continuous flush was administered during the procedure.The patient is fine.No symptoms were reported.  ancillary devices: neuron guide catheter, sl 10 microcatheter, synchro guidewire.

• Brand Name: AXIUM PRIME BRPL 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: 13656388
• Report Number: 2029214-2022-00338
• Device Sequence Number: 20177327
• Product Code: KRD
• UDI-Device Identifier: 00847536031814
• UDI-Public: 00847536031814
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K151447
• 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
• Report Date (Section B): 03/02/2022

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: 05/09/2024
• Device Model Number: APB-1-2-3D-ES
• Device Catalogue Number: APB-1-2-3D-ES
• Device Lot Number: B203442
• 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: 02/17/2022
• Initial Report FDA Received Date: 03/02/2022
• Date Device Manufactured: 05/10/2021
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 67 KG